| Product |
Company |
Generic name |
KEGG DRUG |
ALYFTREK tablet, film coated 125 mg (NDA)
ALYFTREK tablet, film coated 50 mg (NDA)
|
Vertex Pharmaceuticals Incorporated |
vanzacaftor, tezacaftor, and deutivacaftor |
D13024
|
|
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 25 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
|
|
Atorvastatin calcium tablet, film coated 40 mg (ANDA)
|
REMEDYREPACK INC. |
Atorvastatin calcium |
D02258
|
Betamethasone Dipropionate cream .5 mg/g (NDA)
Betamethasone Dipropionate ointment .5 mg/g (NDA)
Betamethasone Dipropionate lotion .5 mg/mL (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
Betamethasone Dipropionate |
D01637
|
|
DICYCLOMINE HYDROCHLORIDE tablet 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
DICYCLOMINE HYDROCHLORIDE |
D00717
|
|
Oxcarbazepine tablet, film coated 600 mg (ANDA)
|
REMEDYREPACK INC. |
Oxcarbazepine |
D00533
|
|
Potassium Citrate tablet, extended release 10 meq (ANDA)
|
REMEDYREPACK INC. |
Potassium Citrate |
D05578
|
|
Divalproex sodium tablet, extended release 250 mg (ANDA)
|
REMEDYREPACK INC. |
Divalproex sodium |
D00304
|
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
|
|
Azithromycin Dihydrate tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Azithromycin Dihydrate |
D02134
|
|
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
|
|
BUPRENORPHINE tablet 2 mg (ANDA)
|
Bryant Ranch Prepack |
BUPRENORPHINE |
D00836
|
fluconazole tablet 50 mg (ANDA)
fluconazole tablet 100 mg (ANDA)
fluconazole tablet 150 mg (ANDA)
fluconazole tablet 200 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
fluconazole |
D00322
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
REMEDYREPACK INC. |
Omeprazole |
D00455
|
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate capsule, extended release 2.5 mg (ANDA)
|
Bryant Ranch Prepack |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate |
D11624
|
|
clonidine hydrochloride tablet .1 mg (ANDA)
|
REMEDYREPACK INC. |
clonidine hydrochloride |
D00604
|
|
Hydromorphone Hydrochloride solution 5 mg/5mL (ANDA)
|
Ascent Pharmaceuticals Inc |
Hydromorphone Hydrochloride |
D00839
|
|
Sodium Bicarbonate injection, solution 42 mg/mL (ANDA)
|
Hospira, Inc. |
SODIUM BICARBONATE |
D01203
|
dapagliflozin and metformin hydrochloride tablet, film coated, extended release 5 mg (ANDA)
dapagliflozin and metformin hydrochloride tablet, film coated, extended release 10 mg (ANDA)
|
Ascend Laboratories, LLC |
dapagliflozin and metformin hydrochloride |
D10586
|
|
Cyclobenzaprine hydrochloride tablet, film coated 5 mg (ANDA)
|
REMEDYREPACK INC. |
Cyclobenzaprine hydrochloride |
D00772
|
|
Sterile Water irrigant 100 mL00mL (NDA)
|
Baxter Healthcare Corporation |
Water |
D00001
|
|
epinephrine injection, solution, concentrate 1 mg/mL (NDA)
|
Baxter Healthcare Corporation |
epinephrine |
D00095
|
|
Tizanidine tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
Tizanidine |
D00776
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 750 mg (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 500 mg (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.5 g (ANDA)
|
Hospira, Inc. |
VANCOMYCIN HYDROCHLORIDE |
D00926
|
Dapagliflozin tablet 5 mg (ANDA)
Dapagliflozin tablet 10 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Dapagliflozin |
D08897
|
Risedronate Sodium tablet, film coated 30.1 mg (NDA AUTHORIZED GENERIC)
Risedronate Sodium tablet, film coated 129 mg (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals, Inc. |
Risedronate Sodium |
D03234
|