| Product |
Company |
Generic name |
KEGG DRUG |
|
Olanzapine tablet, orally disintegrating 10 mg (ANDA)
|
Bryant Ranch Prepack |
Olanzapine |
D00454
|
|
Mitosol kit (NDA)
|
Mobius Therapeutics LLC |
mitomycin |
D00208
|
|
HYLENEX Recombinant injection, solution 150 [USP'U]/mL (BLA)
|
Antares Pharma, Inc. |
Hyaluronidase |
D06604
|
|
Buspirone Hydrochloride tablet 15 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Buspirone Hydrochloride |
D00702
|
|
Diethylpropion Hydrochloride ER tablet, extended release 75 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Diethylpropion Hydrochloride |
D03801
|
aripiprazole tablet 2 mg (ANDA)
aripiprazole tablet 5 mg (ANDA)
aripiprazole tablet 10 mg (ANDA)
aripiprazole tablet 15 mg (ANDA)
aripiprazole tablet 20 mg (ANDA)
aripiprazole tablet 30 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
aripiprazole |
D01164
|
|
Omlonti solution/ drops .02 mg/mL (NDA)
|
Ocuvex Therapeutics, Inc. |
omidenepag isopropyl |
D10966
|
|
Albuterol tablet 4 mg (ANDA)
|
Bryant Ranch Prepack |
albuterol |
D00683
|
|
Moxifloxacin Hydrochloride solution 5 mg/mL (ANDA)
|
Asclemed USA, Inc. |
Moxifloxacin Hydrochloride |
D00874
|
|
Indocyanine Green kit (ANDA)
|
Renew Pharmaceuticals Limited |
Indocyanine Green and Water |
D01342
|
|
Gozellix kit (NDA)
|
Telix Innovations SA |
GOZETOTIDE |
D12257
|
Caspofungin Acetate injection, powder, lyophilized, for solution 5 mg/mL (ANDA)
Caspofungin Acetate injection, powder, lyophilized, for solution 7 mg/mL (ANDA)
|
Fosun Pharma USA Inc. |
Caspofungin Acetate |
D02501
|
|
TEPMETKO tablet 225 mg (NDA)
|
EMD Serono, Inc. |
Tepotinib Hydrochloride |
D11073
|
|
gadoterate meglumine injection 376.9 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadoterate meglumine |
D03355
|
|
gadoterate meglumine injection 376.9 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadoterate meglumine |
D03355
|
|
vancomycin hydrochloride capsule 250 mg (NDA AUTHORIZED GENERIC)
|
Advanced Rx of Tennessee, LLC |
vancomycin hydrochloride |
D00926
|
|
Emtricitabine and tenofovir disoproxil fumarate tablet, film coated 200 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Emtricitabine and tenofovir disoproxil fumarate |
D02297
|
|
Sildenafil tablet, film coated 100 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Sildenafil |
D02229
|
|
Metformin Hydrochloride tablet, film coated 850 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Metformin Hydrochloride |
D00944
|
|
LIKMEZ suspension 100 mg/mL (NDA)
|
Saptalis Pharmaceuticals, LLC |
Metronidazole Oral |
D00409
|
|
Cytarabine injection, solution 100 mg/mL (ANDA)
|
Hospira, Inc. |
CYTARABINE |
D00168
|
Levothyroxine Sodium injection, solution 20 ug/mL (NDA)
Levothyroxine Sodium injection, solution 40 ug/mL (NDA)
Levothyroxine Sodium injection, solution 100 ug/mL (NDA)
|
Fresenius Kabi USA, LLC |
Levothyroxine Sodium |
D11113
|
|
Calcitriol solution 1 ug/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Calcitriol |
D00129
|
Benzonatate capsule 100 mg (ANDA)
Benzonatate capsule 200 mg (ANDA)
|
Asclemed USA, Inc. |
Benzonatate |
D00242
|
|
DIAZEPAM tablet 10 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
DIAZEPAM |
D00293
|
|
Ticagrelor tablet 90 mg (ANDA)
|
Oryza Pharmaceuticals, Inc. |
Ticagrelor |
D09017
|
|
Zolpidem Tartrate tablet, coated 5 mg (ANDA)
|
Advanced Rx of Tennessee, LLC |
Zolpidem Tartrate |
D00706
|
|
Apretude kit (NDA)
|
ViiV Healthcare Company |
Cabotegravir |
D10548
|
prazosin hydrochloride capsule 1 mg (ANDA)
prazosin hydrochloride capsule 2 mg (ANDA)
prazosin hydrochloride capsule 5 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
prazosin hydrochloride |
D00609
|
|
gadobutrol injection 604.72 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadobutrol |
D07420
|
|
gadobutrol injection 604.72 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadobutrol |
D07420
|
Fenofibrate tablet, film coated 54 mg (ANDA)
Fenofibrate tablet, film coated 160 mg (ANDA)
|
American Health Packaging |
Fenofibrate |
D00565
|
|
TEZRULY solution 1 mg/mL (NDA)
|
ANI Pharmaceuticals, Inc. |
Terazosin |
D00610
|
|
GABAPENTIN tablet 600 mg (ANDA)
|
Proficient Rx LP |
Gabapentin |
D00332
|
SUNITINIB MALATE capsule 12.5 mg (ANDA)
SUNITINIB MALATE capsule 25 mg (ANDA)
SUNITINIB MALATE capsule 37.5 mg (ANDA)
SUNITINIB MALATE capsule 50 mg (ANDA)
|
Aurobindo Pharma Limited |
SUNITINIB MALATE |
D06402
|
|
gadobutrol injection 604.72 mg/mL (ANDA)
|
Slate Run Pharmaceuticals, LLC |
gadobutrol |
D07420
|
|
Calcium Acetate capsule 667 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Calcium Acetate |
D00931
|
|
Penicillin V Potassium tablet, film coated 250 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Penicillin V Potassium |
D00497
|
|
GLYCOPYRROLATE liquid 1 mg/5mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
GLYCOPYRROLATE |
D00540
|
Thiotepa injection, powder, lyophilized, for solution 15 mg (ANDA)
Thiotepa injection, powder, lyophilized, for solution 100 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
Thiotepa |
D00583
|