| Product |
Company |
Generic name |
KEGG DRUG |
|
Cyclobenzaprine Hydrochloride tablet, film coated 7.5 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate capsule, extended release 6.25 mg (ANDA)
|
Bryant Ranch Prepack |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate |
D11624
|
|
diltiazem hydrochloride capsule, extended release 120 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
diltiazem hydrochloride |
D00616
|
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g (ANDA)
|
Civica, Inc |
VANCOMYCIN HYDROCHLORIDE |
D00926
|
Buprenorphine and Naloxone Sublingual Film film 2 mg (ANDA)
Buprenorphine and Naloxone Sublingual Film film 4 mg (ANDA)
Buprenorphine and Naloxone Sublingual Film film 8 mg (ANDA)
Buprenorphine and Naloxone Sublingual Film film 12 mg (ANDA)
|
Alvogen Inc. |
Buprenorphine and Naloxone |
D10250
|
|
Diphenoxylate Hydrochloride and Atropine Sulfate tablet 2.5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
diphenoxylate hydrochloride and atropine sulfate |
D00301
|
|
ERIBULIN MESYLATE injection .5 mg/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
eribulin mesylate |
D08914
|
Dapagliflozin and Metformin hydrochloride tablet, film coated, extended release 5 mg (ANDA)
Dapagliflozin and Metformin hydrochloride tablet, film coated, extended release 10 mg (ANDA)
|
Aurobindo Pharma Limited |
Dapagliflozin and Metformin hydrochloride |
D10586
|
|
Levothyroxine sodium tablet 88 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
|
Zonisamide capsule 100 mg (ANDA)
|
REMEDYREPACK INC. |
Zonisamide |
D00538
|
|
ACTIMMUNE injection, solution 100 ug/.5mL (BLA)
|
Horizon Therapeutics USA, Inc. |
Interferon gamma-1b |
D00747
|
|
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 injection, suspension 100 [iU]/mL (BLA)
|
REMEDYREPACK INC. |
insulin aspart |
D04475
|
|
Irinotecan hydrochloride injection, solution 20 mg/mL (ANDA)
|
Actavis Pharma, Inc. |
Irinotecan hydrochloride |
D01061
|
|
Sulfamethoxazole and Trimethoprim suspension 200 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Sulfamethoxazole and Trimethoprim |
D00285
|
|
Rolvedon injection, solution 13.2 mg/.6mL (BLA)
|
Spectrum Pharmaceuticals, Inc. |
eflapegrastim-xnst |
D11188
|
|
Dicyclomine Hydrochloride tablet 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Dicyclomine Hydrochloride |
D00717
|
Morphine sulfate tablet, film coated, extended release 15 mg (ANDA)
Morphine sulfate tablet, film coated, extended release 30 mg (ANDA)
Morphine sulfate tablet, film coated, extended release 100 mg (ANDA)
Morphine sulfate tablet, film coated, extended release 200 mg (ANDA)
Morphine sulfate tablet, film coated, extended release 60 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
morphine sulfate |
D00842
|
FENTANYL patch, extended release 12 ug/h (ANDA)
FENTANYL patch, extended release 25 ug/h (ANDA)
FENTANYL patch, extended release 37.5 ug/h (ANDA)
FENTANYL patch, extended release 50 ug/h (ANDA)
FENTANYL patch, extended release 62.5 ug/h (ANDA)
FENTANYL patch, extended release 75 ug/h (ANDA)
FENTANYL patch, extended release 87.5 ug/h (ANDA)
FENTANYL patch, extended release 100 ug/h (ANDA)
|
Aveva Drug Delivery Systems Inc. |
FENTANYL |
D00320
|
nintedanib capsule 100 mg (ANDA)
nintedanib capsule 150 mg (ANDA)
|
Sandoz Inc |
nintedanib |
D10396
|
|
Umeclidinium Ellipta aerosol, powder 62.5 ug (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
umeclidinium |
D10181
|
CARBIDOPA AND LEVODOPA tablet 10 mg (ANDA)
CARBIDOPA AND LEVODOPA tablet 25 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Carbidopa and Levodopa |
D00253
|
Dapagliflozin and Metformin Hydrochloride tablet, extended release 5 mg (ANDA)
Dapagliflozin and Metformin Hydrochloride tablet, extended release 10 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Dapagliflozin and Metformin Hydrochloride |
D10586
|
|
Lidocaine and Prilocaine cream 25 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
lidocaine and prilocaine |
D02740
|
|
LICART system .013 g (NDA)
|
IBSA Pharma Inc. |
diclofenac epolamine |
D07818
|
|
Betamethasone Dipropionate ointment, augmented .5 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
betamethasone dipropionate |
D01637
|
|
Nitrofurantoin (monohydrate/macrocrystals) capsule 75 mg (ANDA)
|
Major Pharmaceuticals |
Nitrofurantoin (monohydrate/macrocrystals) |
D00439
|
|
Sodium Bicarbonate injection, solution 84 mg/mL (ANDA)
|
Hospira, Inc. |
SODIUM BICARBONATE |
D01203
|
|
Sterile Water injection, solution 100 mL00mL (NDA)
|
Baxter Healthcare Company |
Water |
D00001
|
pantoprazole sodium tablet, delayed release 20 mg (ANDA)
pantoprazole sodium tablet, delayed release 40 mg (ANDA)
|
Granules Pharmaceuticals Inc. |
pantoprazole sodium |
D02593
|
|
Potassium Citrate tablet, extended release 10 meq (ANDA)
|
REMEDYREPACK INC. |
Potassium Citrate |
D05578
|
Potassium Citrate tablet, extended release 5 meq (ANDA)
Potassium Citrate tablet, extended release 10 meq (ANDA)
Potassium Citrate tablet, extended release 15 meq (ANDA)
|
Actavis Pharma, Inc. |
Potassium Citrate |
D05578
|
Diltiazem Hydrochloride capsule, extended release 120 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 180 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 240 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 300 mg (ANDA)
Diltiazem Hydrochloride capsule, extended release 360 mg (ANDA)
|
Upsher-Smith Laboratories, LLC |
Diltiazem hydrochloride |
D00616
|
|
hydrocortisone cream 10 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
Hydrocortisone |
D00088
|
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate capsule, extended release 7.5 mg (ANDA)
|
Bryant Ranch Prepack |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate |
D11624
|
FENTANYL patch, extended release 12 ug/h (ANDA)
FENTANYL patch, extended release 25 ug/h (ANDA)
FENTANYL patch, extended release 37.5 ug/h (ANDA)
FENTANYL patch, extended release 50 ug/h (ANDA)
FENTANYL patch, extended release 62.5 ug/h (ANDA)
FENTANYL patch, extended release 75 ug/h (ANDA)
FENTANYL patch, extended release 87.5 ug/h (ANDA)
FENTANYL patch, extended release 100 ug/h (ANDA)
|
INGENUS PHARMACEUTICALS, LLC |
FENTANYL |
D00320
|
|
TRETINOIN cream 1 mg/g (ANDA)
|
REMEDYREPACK INC. |
tretinoin |
D00094
|
|
Tobramycin solution 300 mg/5mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Tobramycin |
D00063
|
|
Levothyroxine sodium tablet 50 ug (ANDA)
|
REMEDYREPACK INC. |
Levothyroxine Sodium |
D01010
|
|
Morphine Sulfate Extended Release tablet, film coated, extended release 200 mg (ANDA)
|
Bryant Ranch Prepack |
Morphine Sulfate |
D00842
|
Buprenorphine and Naloxone film 2 mg (ANDA)
Buprenorphine and Naloxone film 4 mg (ANDA)
Buprenorphine and Naloxone film 8 mg (ANDA)
Buprenorphine and Naloxone film 12 mg (ANDA)
|
Aveva Drug Delivery Systems Inc. |
buprenorphine and naloxone |
D10250
|