| Product |
Company |
Generic name |
KEGG DRUG |
|
Ibuprofen and famotidine tablet, film coated 26.6 mg (ANDA)
|
Aurobindo Pharma Limited |
Ibuprofen and famotidine |
D11575
|
|
Abirtega tablet 250 mg (ANDA)
|
CivicaScript, LLC |
Abiraterone acetate |
D09701
|
Nystatin and Triamcinolone Acetonide ointment 100000 [USP'U]/g (ANDA)
Nystatin and Triamcinolone Acetonide cream 100000 [USP'U]/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Nystatin and Triamcinolone Acetonide |
D10299
|
|
Tazarotene cream 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Tazarotene |
D01132
|
isoniazid tablet 100 mg (ANDA)
isoniazid tablet 300 mg (ANDA)
|
OMNIVIUM PHARMACEUTICALS LLC. |
isoniazid |
D00346
|
|
Ibuprofen suspension 100 mg/5mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Ibuprofen |
D00126
|
|
Clindamycin Phosphate and Benzoyl Peroxide kit (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clindamycin and Benzoyl Peroxide Gel |
D10602
|
|
Betamethasone Dipropionate lotion, augmented .5 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Betamethasone Dipropionate |
D01637
|
sacubitril and valsartan tablet 24 mg (ANDA)
sacubitril and valsartan tablet 49 mg (ANDA)
sacubitril and valsartan tablet 97 mg (ANDA)
|
Zydus Lifesciences Limited |
sacubitril and valsartan |
D10226
|
sacubitril and valsartan tablet 24 mg (ANDA)
sacubitril and valsartan tablet 49 mg (ANDA)
sacubitril and valsartan tablet 97 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
sacubitril and valsartan |
D10226
|
|
Mometasone Furoate solution 1 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Mometasone Furoate |
D00690
|
|
Krintafel tablet, film coated 150 mg (NDA)
|
GlaxoSmithKline LLC |
tafenoquine succinate |
D10670
|
|
caffeine citrate solution 20 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
caffeine citrate |
D07603
|
|
Methocarbamol Tablets, USP, 500 mg tablet, film coated 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Methocarbamol |
D00402
|
|
Terconazole cream 8 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Terconazole |
D00888
|
ROPINIROLE tablet, film coated .25 mg (ANDA)
ROPINIROLE tablet, film coated 1 mg (ANDA)
|
Cardinal Health 107, LLC |
ROPINIROLE |
D00784
|
Amoxicillin and Clavulanate Potassium tablet, film coated 500 mg (ANDA)
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
Amoxicillin and Clavulanate Potassium tablet, film coated 250 mg (ANDA)
Amoxicillin and Clavulanate Potassium powder, for suspension 200 mg/5mL (ANDA)
Amoxicillin and Clavulanate Potassium powder, for suspension 400 mg/5mL (ANDA)
|
Sandoz Inc |
Amoxicillin and Clavulanate Potassium |
D06485
|
Octreotide Acetate injection, solution 50 ug/mL (ANDA)
Octreotide Acetate injection, solution 100 ug/mL (ANDA)
Octreotide Acetate injection, solution 500 ug/mL (ANDA)
Octreotide Acetate injection, solution 200 ug/mL (ANDA)
Octreotide Acetate injection, solution 1000 ug/mL (ANDA)
|
Sagent Pharmaceuticals |
octreotide acetate |
D06495
|
PRISMASOL BGK2/0 injection 20 g/L (NDA)
PRISMASOL BGK2/3.5 injection 20 g/L (NDA)
PRISMASOL BGK4/2.5 injection 20 g/L (NDA)
PRISMASOL BGK0/2.5 injection 20 g/L (NDA)
PRISMASOL B22GK4/0 injection 20 g/L (NDA)
PRISMASOL BK0/0/1.2 injection 5.4 g/L (NDA)
PRISMASOL BGK4/0/1.2 injection 20 g/L (NDA)
PHOXILLUM BK4/2.5 injection 3.68 g/L (NDA)
PHOXILLUM B22K4/0 injection 3.05 g/L (NDA)
|
Vantive US Healthcare LLC |
magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride |
|
|
Lidocaine Hydrochloride solution 40 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Lidocaine Hydrochloride |
D08127
|
|
Allopurinol tablet 300 mg (ANDA)
|
Major Pharmaceuticals |
allopurinol |
D00224
|
|
Mupirocin ointment 20 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Mupirocin |
D01076
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
Trazodone Hydrochloride tablet 50 mg (ANDA)
|
Cardinal Health 107, LLC |
Trazodone Hydrochloride |
D00820
|
Hydrocortisone Valerate cream 2 mg/g (ANDA)
Hydrocortisone Valerate ointment 2 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Hydrocortisone Valerate |
D02288
|
|
Oralone paste 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Triamcinolone Acetonide |
D00983
|
|
Ciclopirox shampoo 10 mg/.96mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
ciclopirox |
D03488
|
|
Terconazole suppository 80 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Terconazole |
D00888
|
|
POTASSIUM CITRATE EXTENDED RELEASE tablet 10 meq (ANDA)
|
Bryant Ranch Prepack |
POTASSIUM CITRATE |
D05578
|
|
Clindamycin Phosphate and Benzoyl Peroxide kit (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clindamycin and Benzoyl Peroxide Gel |
D10602
|
|
polymyxin b sulfate and trimethoprim sulfate solution/ drops 10000 [iU]/mL (ANDA)
|
REMEDYREPACK INC. |
polymyxin b sulfate and trimethoprim sulfate |
D11086
|
|
Mometasone Furoate cream 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Mometasone Furoate |
D00690
|
|
Clobetasol Propionate lotion .5 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
clobetasol propionate |
D01272
|
|
Naftifine Hydrochloride cream 10 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Naftifine Hydrochloride |
D00883
|
|
Mometasone Furoate ointment 1 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Mometasone Furoate |
D00690
|
|
Betamethasone dipropionate spray .5 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Betamethasone dipropionate |
D01637
|
|
Bumetanide tablet 1 mg (ANDA)
|
REMEDYREPACK INC. |
Bumetanide |
D00247
|
|
FLUZONE HIGH DOSE NORTHERN HEMISPHERE injection, suspension 60 ug/.5mL (BLA)
|
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
D04536
|
|
Clotrimazole and Betamethasone Dipropionate lotion .5 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Clotrimazole and Betamethasone Dipropionate |
D10300
|
|
DOXYCYCLINE HYCLATE tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
DOXYCYCLINE HYCLATE |
D02129
|
|
Acyclovir tablet 400 mg (ANDA)
|
Bryant Ranch Prepack |
Acyclovir |
D00222
|