Midatech Pharma US Inc. 

Zuplenz (ondansetron) oral soluble film

8/6/18 9/6/18   CMP Development, LLC

CaroSpir (spironolactone) Oral Suspension

11/5/21 12/10/21 Released & Replaced (1/13/22) Chartwell Pharmaceuticals, LLC

LymePak (doxycycline hyclate) Tablet

11/17/21   No Response (1/16/2022) Benuvia Therapeutics, Inc

Syndros (dronabinol) Oral Solution

12/16/21 1/28/22   SK Life Science, Inc.

Xcopri (cenobamate) Tablet

12/17/21 1/28/22   Validus Pharmaceuticals, LLC

Equetro (carbamazepine) Extended-Release Capsules 100mg, 200 mg, and 300 mg

7/9/18 7/25/18 Comments = Released (11/2/18)  Galderma Laboratories, L.P. 

Vectical (calcitriol) Ointment, 3 mcg/g

1/10/18 1/29/18 Comments = Fulfilled (7/17/20)  Salix Pharmaceuticals, Inc.

Xifaxan (rifaximin) tablets, 200 mg and 550 mg

8/21/19 10/4/19   Bausch Health US, LLC 

Aplenzin (bupropion hydrobromide) extended-release tablets 174 mg, 348 mg, 522 mg

3/19/19 4/19/19   Endo Pharmaceuticals Inc. Opana ER (oxymorphone hydrochloride) extended-release tablets 10/12/21 11/24/21   Vifor Pharma Inc. Veltassa (patiromer) powder for oral suspension 10/15/21 11/26/21   Supernus Pharmaceuticals Inc. Oxtellar XR (oxcarbazepine) extended-release tablets 10/15/21 No Response   Orexigen Therapeutics, Inc. Contrave (naltrexone hydrochloride/bupropion hydrochloride) extended-release tablets 4/4/17 5/9/17 Fulfilled (10/30/17) AMAG Pharmaceuticals, Inc. Feraheme (ferumoxytol) injection 4/7/17 5/5/17   Sovereign Pharmaceuticals, LLC Obredon (hydrocodone bitartrate and guaifenesin) Oral Solution 4/11/17 5/1/17 Released (10/30/17) West-Ward Pharmaceutical Corp. phenylephrine hydrochloride injection, USP, 10 mg/mL 6/8/17 7/21/17   Mayne Pharma LLC Sorilux (calcipotriene) foam, 0.005% 7/14/17 8/11/17 Fulfilled (5/6/19) Midatech Pharma US, Inc. Zuplenz (ondansetron) oral soluble film 10/3/16 11/15/16   Depomed, Inc. Cambia (diclofenac) powder for oral solution 1/9/17 2/15/17 Released & Replaced (6/20/17) Celgene Corporation Otezla (apremilast) tablets 2/6/17 3/13/17   Insys Development Company, Inc. Syndros (dronabinol oral solution) 2/7/17 2/17/17 Fulfilled (10/18/17) Vernalis (R&D) Limited Moxatag (amoxicillin extended-release) tablets 3/8/17 No Response Released (11/2/17) Salix Pharmaceuticals, Inc. Xifaxan (rifaximin) tablets 9/13/21 10/27/21   Zyla Life Sciences US, Inc. Sprix (ketorolac tromethamine) nasal spray 9/8/21 11/3/21   KVK-Tech, Inc. Apadaz (benzhydrocodone and acetaminophen) tablets 9/7/21 9/16/21   Belcher Pharmatech LLC esomeprazole strontium capsule 8/4/21 10/1/21   Takeda Pharmaceuticals USA, Inc. Brintellix (vortioxetine) Tablets 3/10/15 3/23/15 Fulfilled (4/24/17) Ipsen Biopharm Limited Dysport for Injection (abobotulinumtoxinA) 9/23/15 10/30/15 Fulfilled (7/29/16) Hospira, Inc. Precedex (dexmedetomidine hydrochloride) 9/25/15 11/9/15   Lehigh Valley Technologies, Inc. oxycodone hydrochloride capsules, 5 mg, & oral solution, 100 mg/5 mL 12/8/15 2/2/16   Roxane Laboratories, Inc. morphine sulfate solution & tablets 2/5/16 3/11/16 Fulfilled (6/2/21) Forest Laboratories, Inc. Rectiv (nitroglycerin) Ointment 0.4% 6/25/14 8/6/14 Released (3/27/15) Cumberland Pharmaceuticals Inc. Caldolor (ibuprofen) Injection, 400 mg/4 mL (100 mg/mL) and 800 mg/8 mL (100 mg/mL) 7/15/14 8/20/14 Released & Replaced (12/24/14) Digestive Care, Inc. Pertzye (pancrelipase) Delayed-Release Capsules 11/17/14 12/24/14 Fulfilled (10/6/16) Braintree Laboratories, Inc. Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution 12/2/14 12/15/14 Fulfilled (6/10/16) VistaPharm, Inc. oxycodone hydrochloride oral solution 2/3/15 3/31/16 1863-1 Fulfilled (7/21/21) Lannett Company, Inc. Numbrino (cocaine hydrochloride) nasal solution 7/9/21 8/4/21   Currax Pharmaceuticals LLC Treximet (sumatriptan and naproxen sodium) tablets 6/24/21 8/5/21   Exela Pharma Sciences, LLC Akovaz (ephedrine sulfate injection, USP) 6/16/21 8/2/21   Sanofi-Aventis US LLC Allegra-D 12 Hour Allergy & Congestion (fexofenadine hydrochloride 60 mg and pseudoephedrine 120 mg) extended-release tablet 6/21/21 8/4/21   Merck Sharp & Dohme Corp. Emend (aprepitant) capsules 11/6/13 11/26/13 Fulfilled (12/17/15) Merck Sharp & Dohme Corp Emend (aprepitant) capsules 11/6/13 11/26/13 Fulfilled (12/17/15) UCB, Inc. Cimzia (certolizumab pegol) 11/20/13 12/16/13   ParaPro LLC Natroba (spinosad) topical suspension, 0.9% 12/3/13 1/17/14 Fulfilled (12/30/14) Concordia Pharmaceuticals, Inc. Kapvay (clonidine hydrochloride) 0.1 mg & 0.2 mg extended-release tablets 1/16/14 3/4/14 Fulfilled (8/16/16) Guerbet LLC Dotarem (gadoterate meglumine) 0.5 mmol/mL Injection 1/17/14 No Response (3/19/14) Fulfilled (11/5/14) Fresenius Kabi USA, LLC Smoflipid (lipid injectable emulsion) 5/24/21 6/2/21   Belcher Pharmatech LLC esomeprazole strontium capsule 5/5/21 6/21/21   USWM, LLC Lucemyra (lofexidine hydrochloride) tablets 4/19/21 6/18/21   Rhodes Pharmaceuticals, LP 7/12/17 8/21/17 Fulfilled (6/14/19) Allergan Sales, LLC 7/6/18 8/3/18 Fulfilled (1/31/20) Tris Pharma, Inc. 4/17/21 6/1/21   Hospira, Inc. 4/1/21 4/27/21   Azurity Pharmaceuticals, Inc. 2/25/21 4/9/21   Alexza Pharmaceuticals, Inc. 2/19/21 4/1/21   Azurity Pharmaceuticals, Inc. 1/21/21 3/5/21   Hikma Pharmaceuticals USA, Inc. 12/22/20 2/19/21   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

12/18/20 2/10/21   Shield Therapeutics (UK) Ltd.
Accrufer (ferric maltol) 11/24/20 1/15/21   Pacira Pharmaceuticals, Inc. Exparel (bupivacaine liposome injectable suspension) 11/04/20 11/19/20   Dentsply Pharmaceutical Oraqix (lidocaine and prilocaine periodontal gel) 2.5%/2.5% 06/12/13 07/26/13 User fee was not paid Bayer Healthcare Pharmaceuticals, Inc. Eovist (gadoxetate disodium) Injection 06/13/13 07/26/13 Fulfilled (11/25/14) Wyeth Therapeutics, Inc. Protonix (pantoprazole sodium) Delayed-Release Tablets, 20 mg and 40 mg 06/14/13 07/26/13 Released & Replaced (7/30/13) Janssen Research & Development, LLC

Intelence (etravirine) 200 mg, 100 mg, and 25 mg Tablets

07/15/13 08/27/13 Released & Replaced (6/19/15) Janssen Pharmaceuticals, Inc. Pancreaze (pancrelipase) Delayed-Release Capsules 08/06/13 09/17/13 Fulfilled (3/7/14) Tris Pharma, Inc. QuilliChew ER (methylphenidate hydrochloride) 10/6/20 12/2/20   Vanda Pharmaceuticals, Inc. Fanapt (iloperidone) tablets 10/1/20 11/13/20   Salix Pharmaceuticals, Inc. Trulance (plecanatide) tablet 9/17/20 10/20/20   Helsinn Healthcare SA Aloxi (palonosetron HCl) Injection 4/11/13 5/2/13 Fulfilled (5/27/14) Helsinn Healthcare SA

Aloxi (palonosetron HCl) Injection

4/11/13 5/2/13 Fulfilled (5/27/14) Incline Therapeutics, Inc.

Ionsys (fentanyl iontophoretic transdermal system)

4/12/13 5/9/13 Released (8/30/19) Vicuron Holdings LLC

Eraxis (anidulafungin) Powder for Injection

4/12/13 5/23/13 Fulfilled (9/22/20) Valeant International Bermuda

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

5/7/13 6/21/13 Fulfilled (1/22/14) Portola Pharmaceuticals, Inc. Bevyxxa (betrixaban) 8/14/20 10/09/20   Currax Pharmaceuticals LLC  Onzetra Xsail (sumatriptan nasal powder) 11 mg 8/12/20 9/15/20   Neos Therapeutics, Inc Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets) 7/28/20 8/18/20   Mylan Ireland Limited Arixtra (fondaparinux sodium injection) solution 4/27/20 6/16/20   Rempex Pharmaceuticals, Inc. Vabomere (meropenem-vaborbactam), Powder for Injection, 1 gram/vial 5/01/20 5/15/20   Tris Pharma, Inc. Dyanavel XR (amphetamine) extended-release oral suspension 3/05/20 4/23/20   Arbor Pharmaceuticals, LLC
Edarbi (azilsartan medoxomil) Tablets, 40 mg & 80 mg 2/10/20 3/26/20   Teva Pharmaceutical Industries, Ltd.
ArmonAir RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder 1/30/20 2/19/20   Teva Pharmaceutical Industries, Ltd.
AirDuo Digihaler/AirDuo RespiClick (fluticasone propionate/salmeterol xinafoate inhalation powder) 1/30/20 2/19/20   Akebia Therapeutics

Auryxia (ferric citrate) Tablets

1/31/20 03/13/20   Assertio Therapeutics, Inc.
 Zipsor (diclofenac potassium) liquid filled-capsules) 11/05/19 12/26/19   Supernus Pharmaceuticals, Inc Trokendi XR (topiramate) extended-release capsules 12/09/19 No Response (2/8/20)   Cumberland Pharmaceuticals, Inc. Vibativ (televancin) for Injection, 250 mg & 750 mg 12/12/19 01/15/20   UCB. Inc. Cimzia (certolizumab pegol)

12/20/19

01/31/20   AstraZeneca Pharmaceuticals LP Nexium (esomeprazole magnesium) for delayed release oral suspension 08/21/19 10/3/19   Supernus Pharmaceuticals Trokendi XR (topiramate) extended-release capsules 10/2/19 11/8/19   Ferring Pharmaceuticals, Inc. Prepopik (citric acid, magnesium oxide, and sodium picosulfate) 10/4/19 11/19/19   Braintree Laboratories SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution 7/16/18 8/27/18 Fulfilled(8/5/20) Purdue Pharma Palladone (hydromorphone hydrochloride extended release) Capsules 4/10/13 5/8/13 (PDF - 591KB)* Released
(1/24/17) Genzyme Renvela (sevelamer carbonate) Tablets 4/13/13

5/24/13*

Fulfilled
(12/14/16) Genzyme Renvela (sevelamer carbonate) for Oral Suspension 4/11/13 5/24/13 (PDF - 901KB)* Fulfilled
(12/14/16) Genzyme Hectorol (doxercalciferol capsules) 4/12/13

5/14/13 (PDF - 1.4 MB)*

8/15/13 (PDF - 738K B)*

  Amedra Pharmaceuticals Twinject/Adrenaclick (epinephrine injection, USP 1:1000) 0.15 mg and 0.3 mg 5/13/13 6/27/13 (PDF - 828 KB)* Fulfilled
(1/30/14) The Medicines Company Cleviprex (clevidipine) IV emulsion 0.5 mg/mL 5/14/13 6/10/13 (PDF - 775 KB)*   Salix Pharmaceuticals Apriso (mesalamine) Capsules 6/10/13 07/25/13 (PDF - 75KB)*   Sunovion Pharmaceuticals Xopenex (levalbuterol HCl) Inhalation Solution 6/13/13 7/24/13 (PDF - 246KB)* Fulfilled
(1/22/15) Pfizer Protonix I.V. (pantoprazole sodium) for Injection 6/14/13 7/26/13 (PDF -  235KB)*   Pfizer Protonix I.V. (pantoprazole sodium) for Injection 6/14/13 7/26/13 (PDF - 235 KB)*   Depomed, Inc. Cambia (diclofenac potassium for oral solution) 7/03/13 8/14/13 (PDF -1 MB) Released & Replaced (6/20/17)  Tris Pharma Nexiclon (clonidine) Extended Release Oral Suspension 10/03/13 No Response (12/2/13)   Braintree Laboratories HalfLytely and Bisacodyl Tablet Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet) 3/06/14 4/11/14 (PDF - 820 K B)   Braintree Laboratories Axid (nizatidine) Oral Solution 4/02/14 5/14/14 (PDF - 472 KB)* Released (8/8/17) BioAlliance Pharma Oravig (miconazole) Buccal Tablets, 50 mg 4/04/14 5/9/14 (PDF - 4.8 MB)*   Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.) Sprix (ketorolac tromethamine) Nasal Spray 6/12/14 Supplement (6/18/14) User fee was not paid Depomed, Inc. Zipsor (diclofenac potassium) Liquid-Filled Capsules 1/28/15 2/26/15 (PDF - 4.8 MB)*   Acorda Therapeutics, Inc. Zanaflex (tizanidine) Capsules 3/19/15 4/24/15 (PDF - 2.7 MB)   Meridian Medical Technologies, Inc. DuoDote (atropine and pralidoxime chloride injection) Auto-Injector 5/20/15 7/1/15 (PDF -7 69 KB)*   Supernus Pharmaceuticals, Inc. Trokendi XR (topiramate extended release capsules) 9/29/15 11/12/15 (PDF -308 KB)*   Merck Sharpe & Dohme Corp. Cubicin (daptomycin for injection) 500 mg/vial 3/03/16 4/15/16 (PDF - 1.2 MB) Fulfilled (3/29/17) Purdue Pharmaceutical Products LP Dilaudid & Dilaudid HP Injection 4/21/16 6/23/16 (PDF - 88 KB)   Mallinckrodt Inc. Xartemis XR (oxycodone HCl and acetaminophen) Extended-Release Tablets, 7.5 mg/325 mg 4/25/16 7/15/16 (PDF - 498 KB)* A deferral extension was requested after the fact & granted 9/1/16 Guerbet LLC Dotarem (gadoterate meglumine) Injection 7/07/16 8/15/16 (PDF - 1.48 MB)*   Depomed, Inc. Zipsor (diclofenac potassium) Liquid-Filled Capsules 7/07/16 8/1/16 (PDF - 256 KB)*   Valeant Pharmaceuticals North America LLC Uceris (budesonide) Extended-Release Tablets, 9 mg 10/04/16 11/18/16 PDF - 67 KB)   Supernus Pharmaceuticals, Inc. Oxtellar XR (oxcarbazepine) Extended-Release Tablets 1/12/17 3/10/17 (PDF - 681 KB)*   Pfizer Advil (ibuprofen sodium) tablets, 256 mg 6/12/17 7/21/17  (PDF - 90 KB)   Iroko Pharmaceuticals Zorvolex (diclofenac) Capsules 1-25-18 (PDF - 91 KB) 3-1-18 (PDF - 363 KB)
3-7-18 (PDF - 359KB)   Iroko Pharmaceuticals Tivorbex (indomethacin) Capsules 6-19-18 (PDF - 91 KB) 7-10-18 (PDF - 363 KB)   Vistapharm Inc. Oxycodone Hydrochloride Oral Solution 7-9-19 (PDF - 36 KB) 8-22-19 (PDF - 86 KB)
11-6- 19 (PDF - 714 KB)  

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