Saptalis Pharmaceuticals, LLC

Likmez (metronidazole) oral suspension

9/30/2511/07/25 Trevena, Inc.Olinvyk (oliceridine) injection9/18/2510/30/25 Tris Pharma, Inc.Dyanavel XR (amphetamine) tablets 9/10/2510/27/25 60 Degrees Pharmaceuticals, IncArakoda (tafenoquine) tablet9/8/25No response A deferral extension was granted on 9/10/25 Genentech, Inc.Xofluza (baloxavir marboxil) granules for oral suspension and tablets5/22/247/2/24Fulfilled (12/19/24) Genentech, Inc.Xofluza (baloxavir marboxil) tablet and granules for oral suspension5/22/247/2/24Fulfilled (12/19/24) Gilead Sciences, Inc.Harvoni (ledipasvir and sofosbuvir) tablets5/22/246/27/24Fulfilled (12/19/24) Gilead Sciences, Inc.Sovaldi (sofosbuvir) tablets5/22/246/27/24Fulfilled (12/23/24) Acer Therapeutics Inc.Olpruva (sodium phenylbutyrate) powder11/14/2412/18/24Released and Replaced (10/10/25) Carmel Biosciences, Inc.Prexxartan (valsartan) oral solution8/26/259/19/25A deferral extension was granted on 9/9/25 CMP Development LLCPotassium Phosphates injection8/16/249/27/24Released (5/13/25) Athena Bioscience, LLCQDOLO (tramadol hydrochloride) oral solution 5/22/257/3/25 Innocoll Pharmaceuticals LimitedXaracoll (bupivacaine hydrochloride) implant9/10/24No ResponseA deferral extension was requested and granted on 9/25/24 Keryx Biopharmaceuticals, Inc.Auryxia (ferric citrate) tablets9/10/24No Response Nalpropion Pharmaceuticals LLCContrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets 10/8/2410/21/24Released 10/11/24 Paratek Pharmaceuticals, Inc.Nuzyra (omadacycline) tablets and Nuzyra (omadacycline) injection5/6/256/17/25 Athena Bioscience, LLCQDOLO (tramadol hydrochloride) oral solution4/24/256/6/25 Genus Lifesciences Inc.Oxycodone Hydrochloride capsules and oral solution6/25/248/9/24 8/9/24A deferral extension was requested and granted on 8/2/24 Acacia Pharma, Ltd.Byfavo (remimazolam) for injection4/15/255/29/25 Bausch Health Americas, Inc.DuobrII (halobetasol propionate and tazarotene) lotion4/07/255/15/25 Impel Pharmaceuticals, LLCTrudhesa (dihydroergotamine mesylate) nasal spray3/05/254/17/25 Hikma Pharmaceuticals USA, Inc.Phenylephrine Hydrochloride injection4/03/255/14/25 Hong Kong King-Friend Industrial Company LimitedXenleta (lefamulin) tablets and Xenleta (lefamulin) injection1/10/252/20/25 Heron Therapeutics, Inc.Cinvanti (aprepitant) injection emulsion10/2/2411/14/24 Salix Pharmaceuticals, Inc.Trulance (plecanatide) tablet12/6/2412/23/24A deferral extension was requested and granted on 12/27/24 Keryx Biopharmaceuticals, Inc.Auryxia (ferric citrate) tablets9/20/2411/1/24Released (3/13/25) Nextwave Pharmaceuticals, Inc.QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablet6/13/247/26/24 Innocoll Pharmaceuticals LimitedXaracoll (bupivacaine hydrochloride) implant5/28/247/15/24 Commave Therapeutics SAAzstarys (serdexmethylphenidate chloride and dexmethylphenidate hydrochloride) capsules5/17/246/28/24A deferral extension was requested, after the non-compliance letter was issued, and granted on 8/9/24 Heron Therapeutics, Inc.Zynrelef (bupivacaine and meloxicam) extended-release solution5/16/246/27/24 Trevena, Inc.Olinvyk (oliceridine) injection5/10/246/10/24 US WorldMeds (USVM), LLCLucemyra (lofexidine hydrochloride) tablets4/24/246/7/24 Acacia Pharma LtdByfavo (remimazolam) for injection5/01/246/13/24 Rockwell Medical, Inc.Triferic AVNU (ferric pyrophosphate citrate) injection5/06/24No Response Rockwell Medical, Inc.Triferic (ferric pyrophosphate citrate) powder for solution5/06/24No Response Rockwell Medical, Inc.Triferic (ferric pyrophosphate citrate) for solution5/03/24No Response Ironshore Pharmaceuticals & Development, Inc.Jornay PM (methylphenidate hydrochloride) extended-release capsules4/23/245/29/24 Upsher-Smith Laboratories, LLCQudexy XR (topiramate) extended-release capsules4/22/245/28/24 Zyla Life Sciences US, Inc.Sprix (ketorolac tromethamine) nasal spray4/16/24No response Benuvia Operations, LLCSyndros (dronabinol) oral solution4/12/24No response Athena Bioscience, LLCQdolo (tramadol hydrochloride) oral solution4/25/246/7/24 Aquestive Therapeutics Inc.Zuplenz (ondansetron) oral soluble film4/23/246/7/24 Incyte Corp.Opzelura (ruxolitinib) cream4/23/246/7/24 Azurity Pharmaceuticals Inc.Edarbi (azilsartan medoxomil) tablets4/09/245/24/24 Scilex Pharmaceuticals Inc.Elyxyb (celecoxib) oral solution4/03/245/15/24 Kaleo, Inc.naloxone hydrochloride injection, auto-injector4/03/244/15/24 Neos Therapeutics Brand, LLCCotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets3/27/245/29/24 Noden Pharma Designated Activity CompanyGoprelto (cocaine hydrochloride) solution3/28/244/19/24 Primus Pharmaceuticals IncImpoyz (clobetasol propionate) cream2/21/24No response Primus Pharmaceuticals IncImpoyz (clobetasol propionate) cream7/26/238/23/2023 Hikma Pharmaceuticals USA, Inc.morphine sulfate oral solution and tablets6/14/239/14/23 Chattem, Inc.Allegra-D 12 Hour Allergy and Congestion (fexofenadine hydrochloride; pseudoephedrine hydrochloride) extended release tablets7/21/23No response Ardelyx IncIbsrela (tenapanor) tablets4/19/235/10/23 Nalpropion Pharmaceuticals LLCContrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets4/12/235/10/23 Hikma Pharmaceuticals USA, IncPhenylephrine hydrochloride injection5/31/23No Response Salix Pharmaceuticals Inc.Trulance (plecanatide) tablets3/31/235/10/23 Esperion Therapeutics, Inc. Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe) tablets11/21/2212/26/22 Mylan Ireland LTDArixtra (fondaparinux sodium injection) solution2/28/234/13/23 Helsinn Healthcare SAAkynzeo (netupitant and palonosetron) capsules11/17/2212/21/22Released & Replaced (2/16/23) Assertio Therapeutics, Inc.Cambia (diclofenac potassium) powder for oral solution09/28/2212/07/22 Genus Lifesciences Inc.Tivorbex (indomethacin) capsules09/29/22No ResponseReleased (10/6/23) Primus Pharmaceuticals IncSernivo (betamethasone dipropionate) topical spray03/16/2204/22/22 Salix Pharmaceuticals IncTrulance (plecanatide) tablets06/23/2208/03/22 Midatech Pharma US IncZuplenz (ondansetron) oral soluble film08/6/1809/06/18 CMP Development, LLCCaroSpir (spironolactone) Oral Suspension11/05/2112/10/21Released & Replaced (1/13/22) Chartwell Pharmaceuticals, LLCLymePak (doxycycline hyclate) Tablet11/17/21-No Response (1/16/2022) Benuvia Therapeutics, IncSyndros (dronabinol) Oral Solution12/16/2111/28/22 SK Life Science, Inc.Xcopri (cenobamate) Tablet12/17/2101/28/22Fulfilled (3/2/23) Validus Pharmaceuticals, LLCEquetro (carbamazepine) Extended-Release Capsules 100mg, 200 mg, and 300 mg07/09/187/25/18Comments = Released (11/2/18) Galderma Laboratories, L.P. Vectical (calcitriol) Ointment, 3 mcg/g01/10/181/29/18Comments = Fulfilled (7/17/20) Salix Pharmaceuticals, Inc.Xifaxan (rifaximin) tablets, 200 mg and 550 mg08/21/1910/04/19 Bausch Health US, LLC Aplenzin (bupropion hydrobromide) extended-release tablets 174 mg, 348 mg, 522 mg03/19/1904/19/19 Endo Pharmaceuticals Inc.Opana ER (oxymorphone hydrochloride) extended-release tablets10/12/2111/24/21 Vifor Pharma Inc.Veltassa (patiromer) powder for oral suspension10/15/2111/26/21 Supernus Pharmaceuticals Inc.Oxtellar XR (oxcarbazepine) extended-release tablets10/15/21No Response Orexigen Therapeutics, Inc.Contrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets04/04/1705/09/17Fulfilled (10/30/17) AMAG Pharmaceuticals, Inc.Feraheme (ferumoxytol) injection04/07/1705/05/17 Sovereign Pharmaceuticals, LLCObredon (hydrocodone bitartrate and guaifenesin) Oral Solution04/11/1705/01/17Released (10/30/17) West-Ward Pharmaceutical Corp.phenylephrine hydrochloride injection, USP, 10 mg/mL06/08/1707/21/17 Mayne Pharma LLCSorilux (calcipotriene) foam, 0.005%07/14/1708/11/17Fulfilled (5/6/19) Midatech Pharma US, Inc.Zuplenz (ondansetron) oral soluble film10/03/1611/15/16 Depomed, Inc.Cambia (diclofenac) powder for oral solution01/09/1702/15/17Released & Replaced (6/20/17) Celgene CorporationOtezla (apremilast) tablets02/06/1703/13/17 Insys Development Company, Inc.Syndros (dronabinol oral solution)02/07/1702/17/17Fulfilled (10/18/17) Vernalis (R&D) LimitedMoxatag (amoxicillin extended-release) tablets03/08/17No ResponseReleased (11/2/17) Salix Pharmaceuticals, Inc.Xifaxan (rifaximin) tablets09/13/2110/27/21 Zyla Life Sciences US, Inc.Sprix (ketorolac tromethamine) nasal spray09/08/2111/3/21 KVK-Tech, Inc.Apadaz (benzhydrocodone and acetaminophen) tablets09/07/2109/16/21 Belcher Pharmatech LLCesomeprazole strontium capsule08/04/2110/01/21 Takeda Pharmaceuticals USA, Inc.Brintellix (vortioxetine) Tablets03/10/1503/23/15Fulfilled (4/24/17) Ipsen Biopharm LimitedDysport for Injection (abobotulinumtoxinA)09/23/1510/30/15Fulfilled (7/29/16) Hospira, Inc.Precedex (dexmedetomidine hydrochloride)09/25/1511/09/15 Lehigh Valley Technologies, Inc.oxycodone hydrochloride capsules, 5 mg, & oral solution, 100 mg/5 mL12/08/1502/02/16 Roxane Laboratories, Inc.morphine sulfate solution & tablets02/05/1603/11/16Fulfilled (6/2/21) Forest Laboratories, Inc.Rectiv (nitroglycerin) Ointment 0.4%06/25/1408/06/14Released (3/27/15) Cumberland Pharmaceuticals Inc.Caldolor (ibuprofen) Injection, 400 mg/4 mL (100 mg/mL) and 800 mg/8 mL (100 mg/mL)07/15/1408/20/14Released & Replaced (12/24/14) Digestive Care, Inc.Pertzye (pancrelipase) Delayed-Release Capsules11/17/1412/24/14Fulfilled (10/6/16) Braintree Laboratories, Inc.Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution12/02/1412/15/14Fulfilled (6/10/16) VistaPharm, Inc.oxycodone hydrochloride oral solution02/03/1503/31/161863-1 Fulfilled (7/21/21) Lannett Company, Inc.Numbrino (cocaine hydrochloride) nasal solution07/09/2108/04/21 Currax Pharmaceuticals LLCTreximet (sumatriptan and naproxen sodium) tablets06/24/2108/05/21 Exela Pharma Sciences, LLCAkovaz (ephedrine sulfate injection, USP)06/16/2108/02/21 Sanofi-Aventis US LLCAllegra-D 12 Hour Allergy & Congestion (fexofenadine hydrochloride 60 mg and pseudoephedrine 120 mg) extended-release tablet06/21/2108/04/21 Merck Sharp & Dohme Corp.Emend (aprepitant) capsules11/06/1311/26/13Fulfilled (12/17/15) Merck Sharp & Dohme CorpEmend (aprepitant) capsules11/06/13-Fulfilled (12/17/15) UCB, Inc.Cimzia (certolizumab pegol)11/20/13- ParaPro LLCNatroba (spinosad) topical suspension, 0.9%12/03/1301/17/14Fulfilled (12/30/14) Concordia Pharmaceuticals, Inc.Kapvay (clonidine hydrochloride) 0.1 mg & 0.2 mg extended-release tablets01/16/1403/04/14Fulfilled (8/16/16) Guerbet LLCDotarem (gadoterate meglumine) 0.5 mmol/mL Injection01/17/14No Response (03/19/14)Fulfilled (11/5/14) Fresenius Kabi USA, LLCSmoflipid (lipid injectable emulsion)05/24/2106/02/21 Belcher Pharmatech LLCesomeprazole strontium capsule05/05/2106/21/21 USWM, LLCLucemyra (lofexidine hydrochloride) tablets04/19/2106/18/21 Rhodes Pharmaceuticals, LP

Aptensio XR (methylphenidate hydrochloride extended-release) capsules

07/12/1708/21/17Fulfilled (6/14/19) Allergan Sales, LLCViibryd (vilazodone hydrochloride) tablets07/06/1808/03/18Fulfilled (1/31/20) Tris Pharma, Inc.QuilliChew ER (methylphenidate HCl) extended-release chewable tablets04/17/2106/01/21 Hospira, Inc.Precedex (dexmedetomidine hydrochloride) Injection04/01/2104/27/21 Azurity Pharmaceuticals, Inc.Katerzia (amlodipine besylate USP; amlodipine benzoate) suspension02/25/2104/09/21 Alexza Pharmaceuticals, Inc.Adasuve (loxapine) inhalation powder for oral inhalation use02/19/2104/01/21 Azurity Pharmaceuticals, Inc.Qbrelis (lisinopril) oral solution01/21/2103/05/21 Hikma Pharmaceuticals USA, Inc.Codeine sulfate tablet & oral solution12/22/2002/19/21 Neos Therapeutics, LP

Adzenys XR-ODT (amphetamine Extended-Release Orally Disintegrating Tablets) 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg & 18.8 mg

12/18/202/10/21 Shield Therapeutics (UK) Ltd.Accrufer (ferric maltol)11/24/201/15/21 Pacira Pharmaceuticals, Inc.Exparel (bupivacaine liposome injectable suspension)11/04/2011/19/20 Dentsply PharmaceuticalOraqix (lidocaine and prilocaine periodontal gel) 2.5%/2.5%06/12/1307/26/13User fee was not paid Bayer Healthcare Pharmaceuticals, Inc.Eovist (gadoxetate disodium) Injection06/13/1307/26/13Fulfilled (11/25/14) Wyeth Therapeutics, Inc.Protonix (pantoprazole sodium) Delayed-Release Tablets, 20 mg and 40 mg06/14/1307/26/13Released & Replaced (7/30/13) Janssen Research & Development, LLCIntelence (etravirine) 200 mg, 100 mg, and 25 mg Tablets07/15/1308/27/13Released & Replaced (6/19/15) Janssen Pharmaceuticals, Inc.Pancreaze (pancrelipase) Delayed-Release Capsules08/06/1309/17/13Fulfilled (3/7/14) Tris Pharma, Inc.QuilliChew ER (methylphenidate hydrochloride)10/06/2012/02/20 Vanda Pharmaceuticals, Inc.Fanapt (iloperidone) tablets10/01/2011/13/20 Salix Pharmaceuticals, Inc.Trulance (plecanatide) tablet09/17/2010/20/20 Helsinn Healthcare SAAloxi (palonosetron HCl) Injection04/11/1305/02/13Fulfilled (5/27/14) Helsinn Healthcare SA

Aloxi (palonosetron HCl) Injection

04/11/1305/02/13Fulfilled (5/27/14) Incline Therapeutics, Inc.

Ionsys (fentanyl iontophoretic transdermal system)

04/12/1305/09/13Released (8/30/19) Vicuron Holdings LLC

Eraxis (anidulafungin) Powder for Injection

04/12/1305/23/13Fulfilled (9/22/20) Valeant International Bermuda

Xerese (acyclovir and hydrocortisone) Cream 5%/1%

05/07/1306/21/13Fulfilled (1/22/14) Portola Pharmaceuticals, Inc.Bevyxxa (betrixaban)08/14/2010/09/20 Currax Pharmaceuticals LLCnzetra Xsail (sumatriptan nasal powder) 11 mg08/12/2009/15/20 Neos Therapeutics, IncAdzenys XR-ODT (amphetamine extended-release orally disintegrating tablets)07/28/2008/18/20 Mylan Ireland LimitedArixtra (fondaparinux sodium injection) solution04/27/2006/16/20 Rempex Pharmaceuticals, Inc.Vabomere (meropenem-vaborbactam), Powder for Injection, 1 gram/vial05/01/2005/15/20 Tris Pharma, Inc.Dyanavel XR (amphetamine) extended-release oral suspension03/05/2004/23/20 Arbor Pharmaceuticals, LLCEdarbi (azilsartan medoxomil) Tablets, 40 mg & 80 mg02/10/2003/26/20 Teva Pharmaceutical Industries, Ltd.ArmonAir RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder01/30/2002/19/20 Teva Pharmaceutical Industries, Ltd.AirDuo Digihaler/AirDuo RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder)01/30/2002/19/20 Akebia TherapeuticsAuryxia (ferric citrate) Tablets01/31/2003/13/20 Assertio Therapeutics, Inc.Zipsor (diclofenac potassium) liquid filled-capsules)11/05/1912/26/19 Supernus Pharmaceuticals, IncTrokendi XR (topiramate) extended-release capsules12/09/19No Response (02/08/20) Cumberland Pharmaceuticals, Inc.Vibativ (televancin) for Injection, 250 mg & 750 mg12/12/1901/15/20 UCB. Inc.Cimzia (certolizumab pegol)12/20/1901/31/20 AstraZeneca Pharmaceuticals LPNexium (esomeprazole magnesium) for delayed release oral suspension08/21/1910/03/19 Supernus PharmaceuticalsTrokendi XR (topiramate) extended-release capsules10/02/1911/8/19 Ferring Pharmaceuticals, Inc.Prepopik (citric acid, magnesium oxide, and sodium picosulfate)10/04/1911/19/19 Braintree LaboratoriesSUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution07/16/1808/27/18Fulfilled(8/5/20) Purdue PharmaPalladone (hydromorphone hydrochloride extended release) Capsules04/10/1305/08/13Released (1/24/17) GenzymeRenvela (sevelamer carbonate) Tablets04/13/1305/24/13Fulfilled (12/14/16) GenzymeRenvela (sevelamer carbonate) for Oral Suspension04/11/1305/24/13Fulfilled (12/14/16) GenzymeHectorol (doxercalciferol capsules)04/12/1305/14/13 08/15/13 Amedra PharmaceuticalsTwinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg05/13/1306/27/13Fulfilled (1/30/14) The Medicines CompanyCleviprex (clevidipine) IV emulsion 0.5 mg/mL05/14/1306/10/13 Salix PharmaceuticalsApriso (mesalamine) Capsules06/10/13007/25/13 Sunovion PharmaceuticalsXopenex (levalbuterol HCl) Inhalation Solution06/13/1307/24/13Fulfilled (1/22/15) PfizerProtonix I.V. (pantoprazole sodium) for Injection06/14/1307/26/13 PfizerProtonix I.V. (pantoprazole sodium) for Injection06/14/1307/26/13 Depomed, Inc.Cambia (diclofenac potassium for oral solution)07/03/1308/14/13Released & Replaced (6/20/17) Tris PharmaNexiclon (clonidine) Extended Release Oral Suspension10/03/13No Response (12/02/13) Braintree LaboratoriesHalfLytely and Bisacodyl Tablet Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet)03/06/1404/11/14 Braintree LaboratoriesAxid (nizatidine) Oral Solution04/02/1405/14/14Released (8/8/17) BioAlliance PharmaOravig (miconazole) Buccal Tablets, 50 mg04/04/1405/09/14 Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.)Sprix (ketorolac tromethamine) Nasal Spray06/12/14Supplement (06/18/14)User fee was not paid Depomed, Inc.Zipsor (diclofenac potassium) Liquid-Filled Capsules01/28/1502/26/15 (PDF - 4.8 MB)* Acorda Therapeutics, Inc.Zanaflex (tizanidine) Capsules03/19/1504/24/15 (PDF - 2.7 MB) Meridian Medical Technologies, Inc.DuoDote (atropine and pralidoxime chloride injection) Auto-Injector05/20/1507/01/15 (PDF -7 69 KB)* Supernus Pharmaceuticals, Inc.Trokendi XR (topiramate extended release capsules)09/29/1511/12/15 (PDF -308 KB)* Merck Sharpe & Dohme Corp.Cubicin (daptomycin for injection) 500 mg/vial03/03/1604/15/16 (PDF - 1.2 MB)Fulfilled (3/29/17) Purdue Pharmaceutical Products LPDilaudid & Dilaudid HP Injection04/21/1606/23/16 (PDF - 88 KB) Mallinckrodt Inc.Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg04/25/1607/15/16 (PDF - 498 KB)*A deferral extension was requested after the fact & granted 9/1/16 Guerbet LLCDotarem (gadoterate meglumine) Injection07/07/1608/15/16 (PDF - 1.48 MB)* Depomed, Inc.Zipsor (diclofenac potassium) Liquid-Filled Capsules07/07/1608/01/16 (PDF - 256 KB)* Valeant Pharmaceuticals North America LLCUceris (budesonide) Extended-Release Tablets, 9 mg10/04/1611/18/16 PDF - 67 KB) Supernus Pharmaceuticals, Inc.Oxtellar XR (oxcarbazepine) Extended-Release Tablets01/12/1703/10/17 (PDF - 681 KB)* PfizerAdvil (ibuprofen sodium) tablets, 256 mg06/12/1707/21/17 (PDF - 90 KB) Iroko PharmaceuticalsZorvolex (diclofenac) Capsules01/25/1803/01/18 (PDF - 363 KB) 03/07/18 (PDF - 359KB) Iroko PharmaceuticalsTivorbex (indomethacin) Capsules06/19/1807/10/18 (PDF - 363 KB) Vistapharm Inc.Oxycodone Hydrochloride Oral Solution07/09/1908/22/19 (PDF - 86 KB) 11/06/19 (PDF - 714 KB)