| Product |
Company |
Generic name |
KEGG DRUG |
XTAMPZA ER capsule, extended release 9 mg (NDA)
XTAMPZA ER capsule, extended release 13.5 mg (NDA)
XTAMPZA ER capsule, extended release 18 mg (NDA)
XTAMPZA ER capsule, extended release 27 mg (NDA)
XTAMPZA ER capsule, extended release 36 mg (NDA)
|
Collegium Pharmaceutical, Inc. |
OXYCODONE |
D05312
|
ISOSORBIDE DINITRATE tablet 5 mg (ANDA)
ISOSORBIDE DINITRATE tablet 10 mg (ANDA)
ISOSORBIDE DINITRATE tablet 20 mg (ANDA)
ISOSORBIDE DINITRATE tablet 30 mg (ANDA)
ISOSORBIDE DINITRATE tablet 40 mg (ANDA)
|
Advagen Pharma Ltd |
isosorbide dinitrate |
D00516
|
|
Indomethacin capsule, extended release 75 mg (ANDA)
|
REMEDYREPACK INC. |
Indomethacin |
D00141
|
|
Lorazepam tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
Lorazepam |
D00365
|
BELBUCA film, soluble 75 ug (NDA)
BELBUCA film, soluble 150 ug (NDA)
BELBUCA film, soluble 300 ug (NDA)
BELBUCA film, soluble 450 ug (NDA)
BELBUCA film, soluble 600 ug (NDA)
BELBUCA film, soluble 750 ug (NDA)
BELBUCA film, soluble 900 ug (NDA)
|
BioDelivery Sciences International Inc |
buprenorphine hydrochloride |
D00836
|
Nucynta ER tablet, film coated, extended release 50 mg (NDA)
Nucynta ER tablet, film coated, extended release 100 mg (NDA)
Nucynta ER tablet, film coated, extended release 150 mg (NDA)
Nucynta ER tablet, film coated, extended release 200 mg (NDA)
Nucynta ER tablet, film coated, extended release 250 mg (NDA)
|
Collegium Pharmaceutical, Inc. |
tapentadol hydrochloride |
D10199
|
|
Erythromycin ointment 5 mg/g (ANDA)
|
REMEDYREPACK INC. |
Erythromycin |
D00140
|
Acetazolamide tablet 250 mg (ANDA)
Acetazolamide tablet 125 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Acetazolamide |
D00218
|
AMLODIPINE and OLMESARTAN medoxomil tablet, film coated 5 mg (ANDA)
AMLODIPINE and OLMESARTAN medoxomil tablet, film coated 10 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
AMLODIPINE and OLMESARTAN medoxomil |
D10285
|
|
VIVITROL kit (NDA)
|
Alkermes, Inc. |
naltrexone |
D05113
|
|
Carbamazepine tablet 200 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Carbamazepine |
D00252
|
|
Aminocaproic acid solution .25 g/mL (ANDA)
|
BPI LABS LLC |
Aminocaproic acid |
D00160
|
|
Doxepin Hydrochloride capsule 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
doxepin hydrochloride |
D00814
|
|
rifampin capsule 300 mg (ANDA)
|
A-S Medication Solutions |
rifampin |
D00211
|
|
Oxycodone and Acetaminophen tablet 325 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Oxycodone and Acetaminophen |
D02153
|
|
Enbumyst spray .5 mg/.1mL (NDA)
|
Corstasis USA LLC |
bumetanide |
D00247
|
|
diclofenac epolamine system .013 g (NDA AUTHORIZED GENERIC)
|
Teva Pharmaceuticals USA Inc. |
diclofenac epolamine |
D07818
|
Oxcarbazepine tablet, extended release 150 mg (ANDA)
Oxcarbazepine tablet, extended release 300 mg (ANDA)
Oxcarbazepine tablet, extended release 600 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Oxcarbazepine |
D00533
|
|
Duloxetine capsule, delayed release 60 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Duloxetine |
D01179
|
|
TOBRAMYCIN AND DEXAMETHASONE suspension/ drops 1 mg/mL (ANDA)
|
Bryant Ranch Prepack |
tobramycin and dexamethasone |
D11178
|
|
divalproex sodium tablet, film coated, extended release 500 mg (ANDA)
|
A-S Medication Solutions |
divalproex sodium |
D00304
|
|
Lisinopril tablet 20 mg (ANDA)
|
REMEDYREPACK INC. |
Lisinopril |
D00362
|
|
Levofloxacin tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Levofloxacin |
D00588
|
|
Lisinopril tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
Lisinopril |
D00362
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 500 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
Advanced Rx Pharmacy of Tennessee, LLC |
Trazodone Hydrochloride |
D00820
|
Quetiapine tablet, film coated 25 mg (ANDA)
Quetiapine tablet, film coated 50 mg (ANDA)
Quetiapine tablet, film coated 100 mg (ANDA)
Quetiapine tablet, film coated 200 mg (ANDA)
Quetiapine tablet, film coated 300 mg (ANDA)
Quetiapine tablet, film coated 400 mg (ANDA)
|
Major Pharmaceuticals |
Quetiapine |
D00458
|
|
Naproxen tablet 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Naproxen |
D00118
|
TPOXX injection, solution, concentrate 10 mg/mL (NDA)
TPOXX capsule 200 mg (NDA)
|
SIGA Technologies, Inc. |
tecovirimat monohydrate |
D11557
|
|
Icosapent Ethyl capsule 1 g (ANDA)
|
American Health Packaging |
Icosapent Ethyl |
D01892
|
|
Lorazepam tablet 1 mg (ANDA)
|
REMEDYREPACK INC. |
Lorazepam |
D00365
|
|
Warfarin Sodium tablet 2 mg (ANDA)
|
REMEDYREPACK INC. |
Warfarin Sodium |
D00564
|
|
Furosemide tablet 20 mg (ANDA)
|
Northwind Health Company, LLC |
Furosemide |
D00331
|
|
Paclitaxel injection, powder, lyophilized, for suspension 100 mg/20mL (NDA)
|
Teva Pharmaceuticals, Inc. |
Paclitaxel |
D00491
|
|
Meclizine Hydrochloride tablet 25 mg (ANDA)
|
Northwind Health Company, LLC |
Meclizine Hydrochloride |
D01317
|
Methylphenidate Hydrochloride tablet 5 mg (ANDA)
Methylphenidate Hydrochloride tablet 10 mg (ANDA)
Methylphenidate Hydrochloride tablet 20 mg (ANDA)
|
KVK-TECH, INC. |
Methylphenidate Hydrochloride |
D01296
|
|
Terazosin capsule 1 mg (ANDA)
|
REMEDYREPACK INC. |
Terazosin Hydrochloride |
D11585
|
|
Ciprofloxacin tablet, film coated 250 mg (ANDA)
|
Northwind Health Company, LLC |
Ciprofloxacin Hydrochloride |
D02216
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
Northwind Health Company, LLC |
Ibuprofen |
D00126
|
|
ACCRUFER capsule 30 mg (NDA)
|
Shield TX (UK) Ltd |
Ferric Maltol |
D10833
|