| Product |
Company |
Generic name |
KEGG DRUG |
|
Nabi-HB liquid 1560 [iU]/5mL (BLA)
|
ADMA Biologics, Inc. |
Hepatitis B Immune Globulin (Human) |
D04431
|
|
Furosemide injection, solution 10 mg/mL (ANDA)
|
Avenacy Inc. |
furosemide |
D00331
|
|
Emtricitabine and tenofovir disoproxil fumarate tablet, film coated 200 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Emtricitabine and tenofovir disoproxil fumarate |
D02297
|
|
Clopidogrel bisulfate tablet, film coated 300 mg (ANDA)
|
McKesson Corporation dba SKY Packaging |
Clopidogrel bisulfate |
D00769
|
Junel 21 Day tablet 1 mg (ANDA)
Junel Fe 28 Day kit (ANDA)
Junel 21 Day tablet 1.5 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Norethindrone Acetate and Ethinyl Estradiol |
D04483
|
|
Tiopronin tablet, sugar coated 100 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Tiopronin |
D01430
|
Thiothixene capsule 1 mg (ANDA)
Thiothixene capsule 2 mg (ANDA)
Thiothixene capsule 5 mg (ANDA)
Thiothixene capsule 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Thiothixene |
D00374
|
RANOLAZINE tablet, film coated, extended release 500 mg (ANDA)
RANOLAZINE tablet, film coated, extended release 1000 mg (ANDA)
|
A2A Integrated Pharmaceuticals |
RANOLAZINE |
D05700
|
|
Flumazenil injection, solution .1 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
FLUMAZENIL |
D00697
|
|
Atropine Sulfate solution 10 mg/mL (NDA)
|
Bausch & Lomb Incorporated |
Atropine Sulfate |
D02069
|
|
Midazolam in Sodium Chloride injection, solution 1 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
Midazolam Hydrochloride |
D00696
|
Everolimus tablet .25 mg (ANDA)
Everolimus tablet .5 mg (ANDA)
Everolimus tablet .75 mg (ANDA)
Everolimus tablet 1 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Everolimus |
D02714
|
JYNNEOS injection, suspension 50000000 1/.5mL (BLA)
JYNNEOS injection, powder, lyophilized, for suspension 50000000 1/.5mL (BLA)
Diluent Component liquid .65 mL/.65mL (BLA)
|
Bavarian Nordic A/S |
Vaccinia Virus Modified Strain Ankara-Bavarian Nordic Non-Replicating Antigen |
|
|
Amiodarone Hydrochloride injection, solution 50 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
AMIODARONE HYDROCHLORIDE |
D00636
|
Loestrin 21 Day tablet 1 mg (ANDA)
Loestrin Fe 28 Day kit (ANDA)
Loestrin 21 Day tablet 1.5 mg (ANDA)
|
Teva Women's Health LLC |
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate |
D04483
|
|
LISINOPRIL tablet 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Lisinopril |
D00362
|
|
CILOXAN ointment 3 mg/g (NDA)
|
Sandoz Inc |
ciprofloxacin hydrochloride |
D02216
|
|
Triamcinolone Acetonide paste 1 mg/g (ANDA)
|
Rising Pharma Holdings, Inc. |
Triamcinolone Acetonide |
D00983
|
|
Naproxen tablet 500 mg (ANDA)
|
Asclemed USA, Inc. |
Naproxen |
D00118
|
ZOLPIDEM TARTRATE tablet, extended release 6.25 mg (ANDA)
ZOLPIDEM TARTRATE tablet, extended release 12.5 mg (ANDA)
|
Asclemed USA, Inc. |
Zolpidem Tartrate |
D00706
|
|
CELECOXIB capsule 200 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
CELECOXIB |
D00567
|
|
Potassium Phosphates injection, solution, concentrate 224 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic |
|
|
metronidazole tablet 250 mg (ANDA)
|
AMICI PHARMA INC |
metronidazole |
D00409
|
|
Amoxicillin tablet, coated 875 mg (ANDA)
|
Proficient Rx LP |
Amoxicillin |
D00229
|
Celecoxib capsule 50 mg (ANDA)
Celecoxib capsule 100 mg (ANDA)
Celecoxib capsule 200 mg (ANDA)
Celecoxib capsule 400 mg (ANDA)
|
Asclemed USA, Inc. |
Celecoxib |
D00567
|
|
Fluoxetine capsule 40 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Fluoxetine |
D00823
|
|
OPSYNVI tablet, film coated 10 mg (NDA)
|
Actelion Pharmaceuticals US, Inc. |
macitentan and tadalafil |
D12963
|
|
Estradiol tablet 1 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Estradiol |
D00105
|
|
Fenofibrate tablet, film coated 160 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Fenofibrate |
D00565
|
|
Metformin tablet, extended release 500 mg (ANDA)
|
Proficient Rx LP |
Metformin ER 500 mg |
D00944
|
|
Quetiapine Fumarate tablet, film coated 200 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Quetiapine Fumarate |
D00458
|
|
metronidazole tablet 500 mg (ANDA)
|
AMICI PHARMA INC |
metronidazole |
D00409
|
|
Albuterol Sulfate solution .83 mg/mL (ANDA)
|
Proficient Rx LP |
albuterol sulfate |
D00683
|
|
LISINOPRIL tablet 5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Lisinopril |
D00362
|
|
Cyclobenzaprine Hydrochloride tablet 10 mg (ANDA)
|
EXELAN PHARMACEUTICALS, INC. |
Cyclobenzaprine |
D00772
|
|
Zolpidem Tartrate tablet, coated 5 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Zolpidem Tartrate |
D00706
|
|
LISINOPRIL tablet 40 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Lisinopril |
D00362
|
|
LISINOPRIL tablet 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Lisinopril |
D00362
|
|
Tretinoin cream .25 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
tretinoin |
D00094
|
|
OPSUMIT tablet, film coated 10 mg (NDA)
|
Actelion Pharmaceuticals US, Inc. |
macitentan |
D10135
|