| Product |
Company |
Generic name |
KEGG DRUG |
|
Nitrofurantoin capsule 25 mg (ANDA)
|
Proficient Rx LP |
Nitrofurantoin |
D00439
|
Nifedipine tablet, extended release 30 mg (ANDA)
Nifedipine tablet, extended release 60 mg (ANDA)
Nifedipine tablet, extended release 90 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Nifedipine |
D00437
|
|
ADSOL RED CELL PRESERVATION kit (NDA)
|
Fenwal, Inc. |
anticoagulant citrate phosphate dextrose (cpd) and adsol preservation |
D08745
|
|
Nystatin cream 100000 [USP'U]/g (ANDA)
|
Proficient Rx LP |
Nystatin Cream |
D00202
|
|
SODIUM POLYSTYRENE SULFONATE powder, for suspension 4.1 meq/g (ANDA)
|
SUNRISE PHARMACEUTICAL, INC. |
sodium polystyrene sulfonate |
D03263
|
Estazolam tablet 1 mg (ANDA)
Estazolam tablet 2 mg (ANDA)
|
Novitium Pharma LLC |
Estazolam |
D00311
|
|
Desonide cream .5 mg/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Desonide |
D03696
|
|
North American Coral Snake Antivenin (Equine) injection, powder, for solution 250 [arb'U]0mL (BLA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine) |
|
|
Kit for the Preparation of Technetium Tc99m Sestamibi injection, powder, lyophilized, for solution 1 mg/mL (NDA)
|
Lantheus Medical Imaging, Inc. |
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE |
D01060
|
|
Finasteride tablet, film coated 1 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Finasteride |
D00321
|
|
Nystatin cream 100000 [USP'U]/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Nystatin Cream |
D00202
|
|
FLUOCINONIDE cream 1 mg/g (ANDA)
|
Viona Pharmaceuticals Inc |
FLUOCINONIDE |
D00325
|
|
Metronidazole gel 7.5 mg/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Metronidazole |
D00409
|
|
Nelarabine injection 5 mg/mL (ANDA)
|
Zydus Lifesciences Limited |
Nelarabine |
D05134
|
|
Topotecan hydrochloride injection, powder, lyophilized, for solution 4 mg/4mL (ANDA)
|
Actavis Pharma, Inc. |
Topotecan hydrochloride |
D02168
|
Enoxaparin Sodium injection, solution 30 mg/.3mL (ANDA)
Enoxaparin Sodium injection, solution 40 mg/.4mL (ANDA)
Enoxaparin Sodium injection, solution 60 mg/.6mL (ANDA)
Enoxaparin Sodium injection, solution 80 mg/.8mL (ANDA)
Enoxaparin Sodium injection, solution 100 mg/mL (ANDA)
Enoxaparin Sodium injection, solution 120 mg/.8mL (ANDA)
Enoxaparin Sodium injection, solution 150 mg/mL (ANDA)
|
Italfarmaco SpA |
Enoxaparin Sodium |
D03674
|
|
Nystatin and Triamcinolone Acetonide ointment 100000 [USP'U]/g (ANDA)
|
Viona Pharmaceuticals Inc |
Nystatin and Triamcinolone Acetonide |
D10299
|
|
Nystatin ointment 100000 U/g (ANDA)
|
Viona Pharmaceuticals Inc |
Nystatin |
D00202
|
|
FLUDEOXYGLUCOSE F-18 injection 300 mCi/mL (ANDA)
|
Barbara Ann Karmanos Cancer Hospital |
FLUDEOXYGLUCOSE F-18 |
D01843
|
Triamcinolone Acetonide cream 1 mg/g (ANDA)
Triamcinolone Acetonide cream .25 mg/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Triamcinolone Acetonide |
D00983
|
|
Desmopressin Acetate injection, solution 4 ug/mL (ANDA)
|
Gland Pharma Limited |
Desmopressin Acetate |
D02235
|
Pralatrexate injection 20 mg/mL (NDA AUTHORIZED GENERIC)
Pralatrexate injection 40 mg/2mL (NDA AUTHORIZED GENERIC)
|
Fresenius Kabi USA, LLC |
Pralatrexate |
D05589
|
PIOGLITAZONE tablet 15 mg (ANDA)
PIOGLITAZONE tablet 30 mg (ANDA)
PIOGLITAZONE tablet 45 mg (ANDA)
|
Solco Healthcare LLC |
Pioglitazone |
D00945
|
|
Tafluprost Ophthalmic solution/ drops .0045 mg/.3mL (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
tafluprost |
D06274
|
|
Multiple Electrolytes pH 7.4 injection, solution 526 mg00mL (ANDA)
|
Fresenius Kabi USA, LLC |
sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride |
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
Proficient Rx LP |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Cleviprex emulsion .5 mg/mL (NDA)
|
Fresenius Kabi Austria GmbH |
clevidipine |
D08892
|
|
Aminocaproic acid solution .25 g/mL (ANDA)
|
TruPharma LLC |
Aminocaproic Acid |
D00160
|
|
Multiple Electrolytes pH 5.5 injection, solution 526 mg00mL (ANDA)
|
Fresenius Kabi USA, LLC |
sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride |
|
Lisinopril tablet 2.5 mg (ANDA)
Lisinopril tablet 5 mg (ANDA)
Lisinopril tablet 10 mg (ANDA)
Lisinopril tablet 20 mg (ANDA)
Lisinopril tablet 30 mg (ANDA)
Lisinopril tablet 40 mg (ANDA)
|
Solco healthcare U.S., LLC |
Lisinopril |
D00362
|
|
Midazolam hydrochloride injection, solution 1 mg/mL (ANDA)
|
Gland Pharma Limited |
Midazolam hydrochloride |
D00696
|
|
Ciclopirox Olamine cream 7.7 mg/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Ciclopirox Olamine |
D01364
|
glyburide tablet 1.25 mg (ANDA)
glyburide tablet 2.5 mg (ANDA)
glyburide tablet 5 mg (ANDA)
|
Zydus Lifesciences Limited |
glyburide |
D00336
|
glyburide tablet 1.25 mg (ANDA)
glyburide tablet 2.5 mg (ANDA)
glyburide tablet 5 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
glyburide |
D00336
|
Mexiletine hydrochloride capsule 150 mg (ANDA)
Mexiletine hydrochloride capsule 200 mg (ANDA)
Mexiletine hydrochloride capsule 250 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Mexiletine hydrochloride |
D00639
|
|
Ibuprofen suspension 100 mg/5mL (ANDA)
|
Proficient Rx LP |
Ibuprofen |
D00126
|
Midodrine Hydrochloride tablet 2.5 mg (ANDA)
Midodrine Hydrochloride tablet 5 mg (ANDA)
Midodrine Hydrochloride tablet 10 mg (ANDA)
|
Xiromed, LLC |
midodrine hydrochloride |
D01307
|
|
FLUOCINOLONE ACETONIDE cream .25 mg/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
FLUOCINOLONE ACETONIDE |
D01825
|
Furosemide tablet 20 mg (ANDA)
Furosemide tablet 40 mg (ANDA)
Furosemide tablet 80 mg (ANDA)
|
Leading Pharma, LLC |
Furosemide |
D00331
|
Ketorolac Tromethamine injection, solution 15 mg/mL (ANDA)
Ketorolac Tromethamine injection, solution 30 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
KETOROLAC TROMETHAMINE |
D00813
|