| Product |
Company |
Generic name |
KEGG DRUG |
|
Enoxaparin Sodium injection 100 mg/mL (ANDA)
|
Cardinal Health 107, LLC |
Enoxaparin Sodium |
D03674
|
|
Buprenorphine and Naloxone tablet 8 mg (ANDA)
|
Bryant Ranch Prepack |
Buprenorphine and Naloxone |
D10250
|
|
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
Cardinal Health 107, LLC |
Dicyclomine Hydrochloride |
D00717
|
|
Hydroxyzine hydrochloride tablet 25 mg (ANDA)
|
Preferred Pharmaceuticals Incl |
Hydroxyzine hydrochloride |
D00672
|
|
DESVENLAFAXINE tablet, extended release 25 mg (ANDA)
|
Bryant Ranch Prepack |
DESVENLAFAXINE |
D02570
|
|
Diclofenac Sodium Misoprostol tablet, delayed release 75 mg (ANDA)
|
Bryant Ranch Prepack |
diclofenac sodium and misoprostol |
D11091
|
|
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE tablet 20 mg (ANDA)
|
Bryant Ranch Prepack |
olmesartan medoxomil and hydrochlorothiazide |
D10284
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsule, extended release 1.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsule, extended release 3.75 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsule, extended release 6.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsule, extended release 2.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsule, extended release 5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release capsule, extended release 7.5 mg (ANDA)
|
Rhodes Pharmaceuticals LLC |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE |
D11624
|
|
Zoledronic Acid injection 4 mg/5mL (ANDA)
|
Westminster Pharmaceuticals, LLC |
Zoledronic Acid |
D01968
|
Isosorbide Dinitrate tablet 10 mg (ANDA)
Isosorbide Dinitrate tablet 20 mg (ANDA)
|
Major Pharmaceuticals |
Isosorbide Dinitrate |
D00516
|
|
Folic Acid tablet 1 mg (ANDA)
|
Cardinal Health 107, LLC |
Folic Acid |
D00070
|
Entyvio injection, powder, lyophilized, for solution 300 mg/5mL (BLA)
ENTYVIO injection, solution 108 mg/.68mL (BLA)
ENTYVIO Pen injection, solution 108 mg/.68mL (BLA)
|
Takeda Pharmaceuticals America, Inc. |
vedolizumab |
D08083
|
|
Sodium Phosphates injection, solution 276 mg/mL (NDA)
|
Hospira, Inc. |
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE and SODIUM PHOSPHATE, DIBASIC, ANHYDROUS |
D08815
|
|
pazopanib tablet, film coated 400 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
pazopanib hydrochloride |
D05380
|
|
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 40 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
|
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
|
|
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
|
|
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
|
|
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
|
|
Plenamine solution 1.18 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 |
|
Piperacillin and Tazobactam and Sodium Chloride injection, solution 250 mg/50mL (NDA)
Piperacillin and Tazobactam and Sodium Chloride injection, solution 375 mg/50mL (NDA)
Piperacillin and Tazobactam and Sodium Chloride injection, solution 500 mg00mL (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
|