| Product |
Company |
Generic name |
KEGG DRUG |
|
SCENESSE implant 16 mg6mg (NDA)
|
CLINUVEL INC. |
afamelanotide |
D11334
|
|
Dextrose and Sodium Chloride injection, solution 5 g00mL (ANDA)
|
Fresenius Kabi USA, LLC |
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE |
|
|
Hydrochlorothiazide tablet 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Hydrochlorothiazide |
D00340
|
|
ACYCLOVIR capsule 200 mg (ANDA)
|
Major Pharmaceuticals |
acyclovir |
D00222
|
|
METAXALONE tablet 800 mg (ANDA)
|
DIRECT RX |
METAXALONE |
D00773
|
Carbidopa-levodopa tablet 10 mg (ANDA)
Carbidopa-levodopa tablet 25 mg (ANDA)
|
Advagen Pharma Ltd., |
carbidopa and levodopa |
D00253
|
Vimpat injection 10 mg/mL (NDA)
Vimpat tablet, film coated 50 mg (NDA)
Vimpat tablet, film coated 100 mg (NDA)
Vimpat tablet, film coated 150 mg (NDA)
Vimpat tablet, film coated 200 mg (NDA)
Vimpat solution 10 mg/mL (NDA)
|
UCB, Inc. |
lacosamide |
D07299
|
|
Loperamide Hydrochloride capsule 2 mg (ANDA)
|
Bryant Ranch Prepack |
Loperamide Hydrochloride |
D00729
|
DAPAGLIFLOZIN tablet, film coated 5 mg (ANDA)
DAPAGLIFLOZIN tablet, film coated 10 mg (ANDA)
|
Cipla USA Inc. |
DAPAGLIFLOZIN |
D09763
|
|
Plenamine solution 2.17 g00mL (ANDA)
|
B. Braun Medical Inc. |
LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE |
|
|
Zurnai injection, solution 1.5 mg/.5mL (NDA)
|
Knoa Pharma LLC |
NALMEFENE HYDROCHLORIDE |
D02104
|
|
Tamsulosin Hydrochloride capsule .4 mg (ANDA)
|
REMEDYREPACK INC. |
Tamsulosin Hydrochloride |
D01024
|
Piperacillin and Tazobactam and Sodium Chloride injection, solution 2 g/50mL (NDA)
Piperacillin and Tazobactam and Sodium Chloride injection, solution 3 g/50mL (NDA)
Piperacillin and Tazobactam and Sodium Chloride injection, solution 4 g00mL (NDA)
|
B. Braun Medical Inc. |
Piperacillin and Tazobactam and Sodium Chloride |
D02505
|
|
Metoprolol Tartrate injection, solution 1 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
METOPROLOL TARTRATE |
D00601
|
Allopurinol tablet 100 mg (NDA)
Allopurinol tablet 300 mg (NDA)
|
Actavis Pharma, Inc. |
Allopurinol |
D00224
|
Carbidopa and Levodopa tablet, extended release 25 mg (ANDA)
Carbidopa and Levodopa tablet, extended release 50 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
carbidopa and levodopa |
D00253
|
|
simvastatin tablet, film coated 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
simvastatin |
D00434
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Naltrexone Hydrochloride |
D02095
|
|
BUTALBITAL, ASPIRIN, AND CAFFEINE capsule 325 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
BUTALBITAL, ASPIRIN, AND CAFFEINE |
D11859
|
sirolimus tablet, film coated .5 mg (ANDA)
sirolimus tablet, film coated 1 mg (ANDA)
sirolimus tablet, film coated 2 mg (ANDA)
|
NORTHSTAR RX LLC |
sirolimus |
D00753
|
Hysingla ER tablet, extended release 20 mg (NDA)
Hysingla ER tablet, extended release 30 mg (NDA)
Hysingla ER tablet, extended release 40 mg (NDA)
Hysingla ER tablet, extended release 60 mg (NDA)
Hysingla ER tablet, extended release 80 mg (NDA)
Hysingla ER tablet, extended release 100 mg (NDA)
|
Knoa Pharma LLC |
hydrocodone bitartrate |
D03725
|
Spironolactone tablet, film coated 50 mg (ANDA)
Spironolactone tablet, film coated 100 mg (ANDA)
Spironolactone tablet, film coated 25 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
spironolactone |
D00443
|
OxyContin tablet, film coated, extended release 10 mg (NDA)
OxyContin tablet, film coated, extended release 15 mg (NDA)
OxyContin tablet, film coated, extended release 20 mg (NDA)
OxyContin tablet, film coated, extended release 30 mg (NDA)
OxyContin tablet, film coated, extended release 40 mg (NDA)
OxyContin tablet, film coated, extended release 60 mg (NDA)
OxyContin tablet, film coated, extended release 80 mg (NDA)
|
Knoa Pharma LLC |
oxycodone hydrochloride |
D00847
|
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
Labetalol Hydrochloride |
D00600
|
|
Ondansetron tablet, orally disintegrating 4 mg (ANDA)
|
REMEDYREPACK INC. |
Ondansetron |
D00678
|
Benzonatate capsule 100 mg (ANDA)
Benzonatate capsule 200 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Benzonatate |
D00242
|
|
Misoprostol tablet 100 ug (ANDA)
|
Bryant Ranch Prepack |
Misoprostol |
D00419
|
|
PAVBLU injection, solution 2 mg/.05mL (BLA)
|
Amgen, Inc |
aflibercept-ayyh |
D09574
|
|
Silver Sulfadiazine cream 10 g000g (NDA)
|
NuCare Pharmaceuticals,Inc. |
Silver Sulfadiazine |
D00433
|
|
simvastatin tablet, film coated 80 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
simvastatin |
D00434
|
|
Mupirocin ointment 20 mg/g (ANDA)
|
Sportpharm LLC |
Mupirocin |
D01076
|
Gabapentin capsule 100 mg (ANDA)
Gabapentin capsule 300 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Gabapentin |
D00332
|
|
Finasteride tablet, film coated 5 mg (ANDA)
|
Bryant Ranch Prepack |
Finasteride |
D00321
|
|
Mycophenolate mofetil tablet, film coated 500 mg (ANDA)
|
Major Pharmaceuticals |
Mycophenolate mofetil |
D00752
|
|
Diphenhydramine Hydrochloride injection 50 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
diphenhydramine hydrochloride |
D00669
|
|
doxycycline capsule 100 mg (ANDA)
|
REMEDYREPACK INC. |
doxycycline |
D02129
|
Acetylcysteine solution 100 mg/mL (ANDA)
Acetylcysteine solution 200 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Acetylcysteine |
D00221
|
Lamotrigine Extended-Release tablet, film coated, extended release 100 mg (ANDA)
Lamotrigine Extended-Release tablet, film coated, extended release 200 mg (ANDA)
Lamotrigine Extended-Release tablet, film coated, extended release 300 mg (ANDA)
Lamotrigine Extended-Release tablet, film coated, extended release 250 mg (ANDA)
|
Par Health USA, LLC |
lamotrigine |
D00354
|
SAPHNELO injection, solution 300 mg/2mL (BLA)
SAPHNELO injection, solution 120 mg/.8mL (BLA)
|
AstraZeneca Pharmaceuticals LP |
Anifrolumab-fnia |
D11082
|
|
Hydroxychloroquine sulfate tablet, film coated 200 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Hydroxychloroquine sulfate |
D02114
|