| Product |
Company |
Generic name |
KEGG DRUG |
|
Gabapentin tablet, film coated 600 mg (ANDA)
|
Bryant Ranch Prepack |
GABAPENTIN |
D00332
|
ELFABRIO injection, solution, concentrate 20 mg0mL (BLA)
ELFABRIO injection, solution, concentrate 5 mg/2.5mL (BLA)
|
Chiesi USA, Inc. |
pegunigalsidase alfa |
D11685
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1 g/20mL (ANDA)
|
Eugia US LLC |
Vancomycin Hydrochloride |
D00926
|
Theo-24 capsule, extended release 100 mg (ANDA)
Theo-24 capsule, extended release 200 mg (ANDA)
Theo-24 capsule, extended release 300 mg (ANDA)
Theo-24 capsule, extended release 400 mg (ANDA)
|
ENDO USA, Inc. |
theophylline anhydrous |
D00371
|
|
Zonisamide capsule 100 mg (ANDA)
|
American Health Packaging |
Zonisamide |
D00538
|
|
TOBRAMYCIN injection, powder, lyophilized, for solution 1.2 g/30mL (ANDA)
|
Eugia US LLC |
TOBRAMYCIN |
D02542
|
|
Naloxone Hydrochloride injection, solution .4 mg/mL (ANDA)
|
Eugia US LLC |
Naloxone Hydrochloride |
D01340
|
|
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet 3.75 mg (ANDA)
|
Bryant Ranch Prepack |
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate |
D11624
|
|
Olmesartan Medoxomil and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
Olmesartan Medoxomil and Hydrochlorothiazide |
D10284
|
|
Irbesartan tablet 150 mg (ANDA)
|
Bryant Ranch Prepack |
Irbesartan |
D00523
|
|
Bupropion Hydrochloride XL tablet, extended release 150 mg (ANDA)
|
Northwind Health Company, LLC |
Bupropion Hydrochloride |
D00817
|
|
ORLISTAT capsule 120 mg (NDA AUTHORIZED GENERIC)
|
H2-Pharma LLC |
orlistat |
D04028
|
|
Furosemide solution 40 mg/5mL (ANDA)
|
Precision Dose Inc. |
Furosemide |
D00331
|
|
Pioglitazone tablet 15 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Pioglitazone |
D00945
|
|
Dexmedetomidine Hydrochloride injection, solution 4 ug/mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Dexmedetomidine Hydrochloride |
D01205
|
PREGABALIN capsule 25 mg (ANDA)
PREGABALIN capsule 50 mg (ANDA)
PREGABALIN capsule 75 mg (ANDA)
PREGABALIN capsule 100 mg (ANDA)
PREGABALIN capsule 150 mg (ANDA)
PREGABALIN capsule 200 mg (ANDA)
PREGABALIN capsule 225 mg (ANDA)
PREGABALIN capsule 300 mg (ANDA)
|
Solco Healthcare US, LLC |
pregabalin |
D02716
|
|
scopolamine system 1 mg/3d (ANDA)
|
A-S Medication Solutions |
scopolamine |
D00138
|
|
RISPERIDONE tablet 2 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
RISPERIDONE |
D00426
|
Escitalopram Oxalate tablet, film coated 5 mg (ANDA)
Escitalopram Oxalate tablet, film coated 10 mg/21 (ANDA)
Escitalopram Oxalate tablet, film coated 20 mg/21 (ANDA)
|
NorthStar RxLLC |
Escitalopram Oxalate |
D02567
|
|
AZITHROMYCIN powder, for suspension 200 mg/5mL (ANDA)
|
NuCare Pharmaceuticals,Inc. |
AZITHROMYCIN |
D06390
|
Lurasidone Hydrochloride tablet, coated 60 mg (ANDA)
Lurasidone Hydrochloride tablet, coated 20 mg (ANDA)
Lurasidone Hydrochloride tablet, coated 40 mg (ANDA)
Lurasidone Hydrochloride tablet, coated 80 mg (ANDA)
Lurasidone Hydrochloride tablet, coated 120 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Lurasidone Hydrochloride |
D04820
|
|
Bupropion Hydrochloride XL tablet, extended release 300 mg (ANDA)
|
A-S Medication Solutions |
bupropion hydrochloride |
D00817
|
Doxepin tablet 3 mg (ANDA)
Doxepin tablet 6 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Doxepin |
D00814
|
|
Melphalan Hydrochloride kit (ANDA)
|
Dr.Reddy's Laboratories Inc |
Melphalan Hydrochloride |
D08173
|
Lidocaine Hydrochloride injection, solution 10 mg/mL (ANDA)
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
NorthStar RxLLC |
Lidocaine Hydrochloride |
D02086
|
HYDROMORPHONE HYDROCHLORIDE tablet 2 mg (ANDA)
HYDROMORPHONE HYDROCHLORIDE tablet 4 mg (ANDA)
HYDROMORPHONE HYDROCHLORIDE tablet 8 mg (ANDA)
|
Aurolife Pharma, LLC |
HYDROMORPHONE HYDROCHLORIDE |
D00839
|
|
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate tablet, film coated 600 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate |
D10851
|
|
TAZICEF injection, powder, for solution 6 g (ANDA)
|
Hospira, Inc. |
CEFTAZIDIME |
D00921
|
Acarbose tablet 25 mg (ANDA)
Acarbose tablet 50 mg (ANDA)
Acarbose tablet 100 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Acarbose |
D00216
|
Timolol maleate solution/ drops 2.5 mg/mL (ANDA)
Timolol maleate solution/ drops 5 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Timolol maleate |
D00603
|
Doxazosin tablet 1 mg (ANDA)
Doxazosin tablet 2 mg (ANDA)
Doxazosin tablet 4 mg (ANDA)
Doxazosin tablet 8 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Doxazosin |
D00608
|
|
Melphalan Hydrochloride kit (ANDA)
|
Qilu Pharmaceutical Co., Ltd. |
melphalan hydrochloride |
D08173
|
Levofloxacin injection, solution 250 mg/50mL (ANDA)
levofloxacin injection, solution 500 mg00mL (ANDA)
levofloxacin injection, solution 750 mg50mL (ANDA)
|
Gland Pharma Limited |
Levofloxacin |
D00588
|
Maraviroc tablet, film coated 150 mg (ANDA)
Maraviroc tablet, film coated 300 mg (ANDA)
|
Hetero Labs Limited |
Maraviroc |
D06670
|
Atropine Sulfate solution .4 mg/mL (ANDA)
Atropine Sulfate solution 1 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Atropine Sulfate |
D02069
|
|
Sodium Chloride injection, solution 9 g000mL (ANDA)
|
CODAN US CORPORATION |
SODIUM CHLORIDE |
D02056
|
|
Emtricitabine and tenofovir disoproxil fumarate tablet, film coated 200 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Emtricitabine and tenofovir disoproxil fumarate |
D02297
|
Dexamethasone Sodium Phosphate injection 4 mg/mL (ANDA)
Dexamethasone Sodium Phosphate injection 10 mg/mL (ANDA)
|
Gland Pharma Limited |
Dexamethasone Sodium Phosphate |
D00975
|
|
Natazia kit (NDA)
|
Bayer HealthCare Pharmaceuticals Inc. |
estradiol valerate and estradiol valerate/dienogest |
D10461
|
|
Dexamethasone Sodium Phosphate injection, solution 4 mg/mL (ANDA)
|
Phlow Corporation |
DEXAMETHASONE SODIUM PHOSPHATE |
D00975
|