| Product |
Company |
Generic name |
KEGG DRUG |
Tetracycline Hydrochloride capsule 250 mg (ANDA)
Tetracycline Hydrochloride capsule 500 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Tetracycline Hydrochloride |
D02122
|
|
IBU tablet 400 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Ibuprofen |
D00126
|
Cyclosporine capsule, gelatin coated 25 mg (ANDA)
Cyclosporine capsule, gelatin coated 100 mg (ANDA)
|
Apotex Corp. |
Cyclosporine |
D00184
|
|
Potassium Acetate injection, solution, concentrate 196.3 mg/mL (NDA)
|
Hospira, Inc. |
POTASSIUM ACETATE |
D01154
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Macleods Pharmaceuticals Limited |
Lidocaine |
D00358
|
|
Potassium Acetate injection, solution, concentrate 3.93 g/20mL (NDA)
|
Hospira, Inc. |
POTASSIUM ACETATE |
D01154
|
|
Amlodipine Besylate tablet 2.5 mg (ANDA)
|
REMEDYREPACK INC. |
Amlodipine besylate |
D00615
|
|
Gemcitabine injection, solution 38 mg/mL (NDA)
|
Hospira, Inc. |
GEMCITABINE |
D01155
|
|
Duavee tablet, film coated .45 mg (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
conjugated estrogens/bazedoxifene |
D10579
|
|
Potassium Acetate injection, solution, concentrate 196.3 mg/mL (NDA)
|
Hospira, Inc. |
POTASSIUM ACETATE |
D01154
|
|
OMEPRAZOLE capsule, delayed release pellets 40 mg (ANDA)
|
Golden State Medical Supply, Inc. |
OMEPRAZOLE |
D00455
|
Prempro tablet, sugar coated .3 mg (NDA)
Prempro tablet, sugar coated .45 mg (NDA)
Prempro tablet, sugar coated .625 mg (NDA)
Premphase kit (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
conjugated estrogens and medroxyprogesterone acetate |
|
|
Folic Acid tablet 1 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Folic Acid |
D00070
|
Meclizine Hydrochloride tablet 12.5 mg (ANDA)
Meclizine Hydrochloride tablet 25 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Meclizine Hydrochloride |
D01317
|
|
lithium carbonate capsule 150 mg (ANDA)
|
REMEDYREPACK INC. |
lithium carbonate |
D00801
|
|
acyclovir capsule 200 mg (ANDA)
|
REMEDYREPACK INC. |
acyclovir |
D00222
|
|
Indomethacin capsule 25 mg (ANDA)
|
REMEDYREPACK INC. |
Indomethacin |
D00141
|
|
Cablivi kit (BLA)
|
Genzyme Corporation |
caplacizumab |
D11160
|
Alkindi Sprinkle granule .5 mg (NDA)
Alkindi Sprinkle granule 1 mg (NDA)
Alkindi Sprinkle granule 2 mg (NDA)
Alkindi Sprinkle granule 5 mg (NDA)
|
Eton Pharmaceuticals, Inc. |
Hydrocortisone |
D00088
|
|
Bromocriptine mesylate tablet 2.5 mg (ANDA)
|
REMEDYREPACK INC. |
Bromocriptine mesylate |
D00780
|
|
ANDEXXA injection, powder, lyophilized, for solution 200 mg/20mL (BLA)
|
AstraZeneca Pharmaceuticals LP |
andexanet alfa |
D11029
|
Sephience powder 250 mg (NDA)
Sephience powder 1000 mg (NDA)
|
PTC Therapeutics Inc. |
sepiapterin |
D12286
|
|
loteprednol etabonate suspension/ drops 2 mg/mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
loteprednol etabonate |
D01689
|
Metformin tablet, extended release 500 mg (ANDA)
Metformin tablet, extended release 1000 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
metformin |
D00944
|
|
Chlorhexidine Gluconate rinse 1.2 mg/mL (ANDA)
|
Xttrium Laboratories, Inc. |
Chlorhexidine Gluconate |
D00858
|
|
Chlorhexidine Gluconate rinse 1.2 mg/mL (ANDA)
|
Xttrium Laboratories, Inc. |
Chlorhexidine Gluconate |
D00858
|
|
ANTISEPTIC SKIN CLEANSER solution 4 g00mL (NDA)
|
Xttrium Laboratories, Inc. |
CHLORHEXIDINE GLUCONATE |
D00858
|
Atovaquone and Proguanil Hydrochloride tablet, film coated 250 mg (ANDA)
Atovaquone and Proguanil Hydrochloride Pediatric tablet, film coated 62.5 mg (ANDA)
|
Glenmark Pharmaceuticals Inc.,USA |
Atovaquone and Proguanil Hydrochloride Pediatric |
D02472
|
|
Dantrium injection 20 mg/60mL (NDA)
|
Par Health USA, LLC |
dantrolene sodium |
D02274
|
|
Nalbuphine Hydrochloride injection 10 mg/mL (ANDA)
|
Henry Schein, Inc. |
nalbuphine hydrochloride |
D00843
|
|
Amitriptyline Hydrochloride tablet, film coated 150 mg (ANDA)
|
Coupler LLC |
Amitriptyline Hydrochloride |
D00809
|
|
bupropion Hydrochloride tablet 100 mg (ANDA)
|
Coupler LLC |
bupropion Hydrochloride |
D00817
|
|
Mirtazapine tablet, film coated 30 mg (ANDA)
|
Coupler LLC |
Mirtazapine |
D00563
|
|
meloxicam tablet 7.5 mg (ANDA)
|
Coupler LLC |
meloxicam |
D00969
|
|
SIMVASTATIN tablet, film coated 10 mg (ANDA)
|
Coupler LLC |
SIMVASTATIN |
D00434
|
|
PREDNISONE tablet 50 mg (ANDA)
|
Coupler LLC |
PREDNISONE |
D00473
|
|
Atenolol tablet 50 mg (ANDA)
|
Coupler LLC |
Atenolol |
D00235
|
|
Atenolol tablet 25 mg (ANDA)
|
Coupler LLC |
Atenolol |
D00235
|
|
Ibuprofen tablet 800 mg (ANDA)
|
Coupler LLC |
Ibuprofen |
D00126
|
SILDENAFIL CITRATE tablet 50 mg (ANDA)
SILDENAFIL CITRATE tablet 100 mg (ANDA)
SILDENAFIL CITRATE tablet 25 mg (ANDA)
|
NIVAGEN PHARMACEUTICALS, INC. |
SILDENAFIL CITRATE |
D02229
|