| Product |
Company |
Generic name |
KEGG DRUG |
|
Amoxicillin powder, for suspension 200 mg/5mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amoxicillin |
D00229
|
|
Naproxen tablet 500 mg (ANDA)
|
Bryant Ranch Prepack |
Naproxen |
D00118
|
|
Azithromycin tablet, film coated 500 mg (ANDA)
|
Bryant Ranch Prepack |
Azithromycin |
D02134
|
|
Lidocaine Hydrochloride solution 20 mg/mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Lidocaine Hydrochloride |
D08127
|
|
Pregabalin capsule 300 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Pregabalin |
D02716
|
Haloperidol tablet .5 mg (ANDA)
Haloperidol tablet 2 mg (ANDA)
Haloperidol tablet 1 mg (ANDA)
Haloperidol tablet 5 mg (ANDA)
Haloperidol tablet 10 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
haloperidol |
D00136
|
|
BRIMONIDINE TARTRATE solution/ drops 2 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
BRIMONIDINE TARTRATE |
D02076
|
FLUZONE QIV SH 2025 injection, suspension 15 ug/.5mL (BLA)
Fluzone QIV SH 2025 injection, suspension 15 ug/.5mL (BLA)
|
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
|
olmesartan medoxomil tablet, film coated 5 mg (ANDA)
olmesartan medoxomil tablet, film coated 20 mg (ANDA)
olmesartan medoxomil tablet, film coated 40 mg (ANDA)
|
Jubilant Cadista Pharmacuticals Inc. |
olmesartan medoxomil |
D01204
|
Methylphenidate Hydrochloride solution 5 mg/5mL (ANDA)
Methylphenidate Hydrochloride solution 10 mg/5mL (ANDA)
|
Cranbury Pharmaceuticals, LLC |
Methylphenidate Hydrochloride |
D01296
|
|
Prochlorperazine Edisylate injection 5 mg/mL (ANDA)
|
Nexus Pharmaceuticals LLC |
Prochlorperazine Edisylate |
D02609
|
|
Acetylcysteine injection, solution 200 mg/mL (ANDA)
|
Glenmark Pharmaceuticals Inc., USA |
Acetylcysteine |
D00221
|
|
zoledronic acid injection, solution .05 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
zoledronic acid |
D01968
|
Ibuprofen tablet, film coated 400 mg (ANDA)
Ibuprofen tablet, film coated 800 mg (ANDA)
Ibuprofen tablet, film coated 600 mg (ANDA)
|
Strides Pharma Inc. |
Ibuprofen |
D00126
|
|
zoledronic acid injection, solution .04 mg/mL (NDA)
|
Sagent Pharmaceuticals |
zoledronic acid |
D01968
|
|
Methocarbamol injection 100 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Methocarbamol |
D00402
|
|
vigabatrin powder, for solution 500 mg0mL (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
vigabatrin |
D00535
|
Ibuprofen tablet, film coated 800 mg (ANDA)
Ibuprofen tablet, film coated 600 mg (ANDA)
Ibuprofen tablet, film coated 400 mg (ANDA)
|
Strides Pharma Science Limited |
Ibuprofen |
D00126
|
SUTENT capsule 12.5 mg (NDA)
SUTENT capsule 50 mg (NDA)
|
U.S. Pharmaceuticals |
Sunitinib malate |
D06402
|
|
Bimatoprost solution/ drops .3 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Bimatoprost |
D02724
|
|
vigabatrin powder, for solution 500 mg0mL (ANDA)
|
Zydus Lifesciences Limited |
vigabatrin |
D00535
|
|
Clonidine Hydrochloride tablet .3 mg (ANDA)
|
Bryant Ranch Prepack |
Clonidine Hydrochloride |
D00604
|
|
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE capsule 300 mg (ANDA)
|
Bryant Ranch Prepack |
butalbital, acetaminophen and caffeine |
D11850
|
|
DAPTACEL injection, suspension 5 ug/.5mL (BLA)
|
Sanofi Pasteur Inc. |
corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen |
D05356
|
|
Paroxetine tablet, film coated 40 mg (ANDA)
|
Bryant Ranch Prepack |
Paroxetine |
D02260
|
Buspirone Hydrochloride capsule 7.5 mg (ANDA)
Buspirone Hydrochloride capsule 10 mg (ANDA)
Buspirone Hydrochloride capsule 15 mg (ANDA)
|
EPIC PHARMA, LLC |
Buspirone Hydrochloride |
D00702
|
|
CHLOROTHIAZIDE SODIUM injection, powder, lyophilized, for solution 500 mg8mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
CHLOROTHIAZIDE SODIUM |
D03471
|
|
Colchicine capsule .6 mg (NDA)
|
Major Pharmaceuticals |
Colchicine |
D00570
|
Clindamycin phosphate injection, solution 600 mg/50mL (ANDA)
Clindamycin phosphate injection, solution 900 mg/50mL (ANDA)
|
Baxter Healthcare Corporation |
Clindamycin phosphate |
D01073
|
Clobazam tablet 10 mg (ANDA)
Clobazam tablet 20 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Clobazam |
D01253
|
|
Sodium Ferric Gluconate Complex in Sucrose injection 12.5 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Sodium Ferric Gluconate Complex in Sucrose |
D05859
|
|
ITRACONAZOLE capsule 100 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
itraconazole |
D00350
|
HERCESSI injection, powder, lyophilized, for solution 150 mg/7.4mL (BLA)
HERCESSI injection, powder, lyophilized, for solution 420 mg/20mL (BLA)
|
Accord BioPharma Inc. |
trastuzumab-strf |
D03257
|
Escitalopram tablet, film coated 10 mg (ANDA)
Escitalopram tablet, film coated 20 mg (ANDA)
|
American Health Packaging |
Escitalopram Oxalate |
D02567
|
|
Memantine Hydrochloride tablet 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Memantine Hydrochloride |
D04905
|
|
Sertraline Hydrochloride tablet 100 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sertraline Hydrochloride |
D00825
|
|
Diclofenac Potassium tablet, film coated 50 mg (ANDA)
|
Marlex Pharmaceuticals, Inc. |
diclofenac potassium |
D00903
|
Doxepin tablet 3 mg (ANDA)
Doxepin tablet 6 mg (ANDA)
|
Strides Pharma Science Limited |
doxepin hydrochloride |
D00814
|
|
Hydrocodone Bitartrate and Acetaminophen tablet 300 mg (ANDA)
|
Bryant Ranch Prepack |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
Doxycycline tablet 50 mg (ANDA)
Doxycycline tablet 75 mg (ANDA)
Doxycycline tablet 100 mg (ANDA)
Doxycycline tablet 150 mg (ANDA)
|
Strides Pharma Science Limited |
doxycycline |
D00307
|