| Product |
Company |
Generic name |
KEGG DRUG |
|
simvastatin tablet, film coated 40 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
simvastatin |
D00434
|
|
ECONAZOLE NITRATE cream 10 mg/g (ANDA)
|
Aurobindo Pharma Limited |
ECONAZOLE NITRATE |
D00881
|
|
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
olmesartan medoxomil and hydrochlorothiazide |
D10284
|
Butrans patch, extended release 5 ug/h (NDA)
Butrans patch, extended release 10 ug/h (NDA)
Butrans patch, extended release 20 ug/h (NDA)
Butrans patch, extended release 15 ug/h (NDA)
Butrans patch, extended release 7.5 ug/h (NDA)
|
Knoa Pharma LLC |
buprenorphine |
D07132
|
|
Carvedilol tablet, film coated 25 mg (ANDA)
|
Bryant Ranch Prepack |
Carvedilol |
D00255
|
|
HYDROXYZINE HYDROCHLORIDE tablet, film coated 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
hydroxyzine hydrochloride |
D00672
|
|
Lithium Carbonate capsule 600 mg (ANDA)
|
REMEDYREPACK INC. |
Lithium Carbonate |
D00801
|
Docetaxel injection 20 mg/mL (ANDA)
Docetaxel injection 80 mg/4mL (ANDA)
Docetaxel injection 160 mg/8mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Docetaxel |
D02165
|
|
Desoximetasone cream .5 mg/g (ANDA)
|
Saptalis Pharmaceuticals, LLC. |
Desoximetasone |
D03697
|
Methylphenidate Hydrochloride tablet, film coated, extended release 18 mg (ANDA)
Methylphenidate Hydrochloride tablet, film coated, extended release 36 mg (ANDA)
Methylphenidate Hydrochloride tablet, film coated, extended release 54 mg (ANDA)
Methylphenidate Hydrochloride tablet, film coated, extended release 27 mg (ANDA)
|
Actavis Pharma, Inc. |
Methylphenidate Hydrochloride |
D01296
|
DOXEPIN HYDROCHLORIDE capsule 10 mg (ANDA)
DOXEPIN HYDROCHLORIDE capsule 25 mg (ANDA)
DOXEPIN HYDROCHLORIDE capsule 50 mg (ANDA)
DOXEPIN HYDROCHLORIDE capsule 75 mg (ANDA)
DOXEPIN HYDROCHLORIDE capsule 100 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
DOXEPIN HYDROCHLORIDE |
D00814
|
|
Brompheniramine maleate, pseudoephedrine hydrochloride, syrup 2 mg/5mL (ANDA)
|
Eywa Pharma Inc |
Brompheniramine maleate, pseudoephedrine hydrochloride, |
D11647
|
|
Dsuvia tablet 30 ug (NDA)
|
AcelRx Pharmaceuticals, Inc. |
Sufentanil |
D00845
|
|
Metaxalone tablet 800 mg (ANDA)
|
Direct_Rx |
Metaxalone |
D00773
|
|
VUITY solution/ drops 12.5 mg/mL (NDA)
|
AbbVie Inc. |
Pilocarpine Hydrochloride |
D02200
|
|
Furosemide injection, solution 10 mg/mL (NDA)
|
Cardinal Health 107, LLC |
Furosemide |
D00331
|
|
Penicillin V Potassium tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Penicillin V Potassium |
D00497
|
|
Metaxalone tablet 800 mg (ANDA)
|
Direct_Rx |
Metaxalone |
D00773
|
|
Hydrochlorothiazide capsule 12.5 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Hydrochlorothiazide |
D00340
|
|
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
|
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
|