| Product |
Company |
Generic name |
KEGG DRUG |
|
Pregabalin capsule 75 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
PREGABALIN |
D02716
|
amlodipine besylate tablet 2.5 mg (ANDA)
amlodipine besylate tablet 5 mg (ANDA)
amlodipine besylate tablet 10 mg (ANDA)
|
POLYGEN PHARMACEUTICALS INC. |
amlodipine besylate |
D00615
|
|
Gabapentin capsule 100 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Gabapentin |
D00332
|
|
MITOMYCIN injection, powder, lyophilized, for solution 40 mg/80mL (ANDA)
|
Gland Pharma Limited |
MITOMYCIN |
D00208
|
Rizatriptan Benzoate tablet 5 mg (ANDA)
Rizatriptan Benzoate tablet 10 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Rizatriptan Benzoate |
D00675
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Proficient Rx LP |
Albuterol Sulfate |
D00683
|
|
NEUROLITE kit (NDA)
|
Lantheus Medical Imaging, Inc. |
Bicisate dihydrochloride |
|
Tolterodine tartrate tablet, film coated 1 mg (ANDA)
Tolterodine tartrate tablet, film coated 2 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Tolterodine tartrate |
D01148
|
|
Volumex injection, solution .025 mCi/mL (BLA)
|
Iso-Tex Diagnostics, Inc. |
Iodinated I-131 Albumin |
D02796
|
|
Succinylcholine Chloride injection, solution 20 mg/mL (ANDA)
|
Gland Pharma Limited |
Succinylcholine Chloride |
D00766
|
Hydroxyzine Hydrochloride tablet, film coated 10 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 25 mg (ANDA)
Hydroxyzine Hydrochloride tablet, film coated 50 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Hydroxyzine Hydrochloride |
D00672
|
|
METOPROLOL SUCCINATE tablet, film coated, extended release 50 mg (ANDA)
|
Proficient Rx LP |
METOPROLOL SUCCINATE |
D00635
|
|
Etodolac tablet, film coated 500 mg (ANDA)
|
Proficient Rx LP |
Etodolac |
D00315
|
|
Nitrofurantoin capsule 25 mg (ANDA)
|
Proficient Rx LP |
Nitrofurantoin |
D00439
|
|
Terconazole suppository 80 mg (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Terconazole |
D00888
|
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
|
|
CYPROHEPTADINE HYDROCHLORIDE tablet 4 mg (ANDA)
|
Strides Pharma Science Limited |
CYPROHEPTADINE HYDROCHLORIDE |
D02234
|
|
Nystatin cream 100000 [USP'U]/g (ANDA)
|
Cosette Pharmaceuticals, Inc. |
Nystatin Cream |
D00202
|
|
FLUOCINONIDE cream 1 mg/g (ANDA)
|
Viona Pharmaceuticals Inc |
FLUOCINONIDE |
D00325
|
Olmesartan medoxomil tablet 5 mg (ANDA)
Olmesartan medoxomil tablet 20 mg (ANDA)
Olmesartan medoxomil tablet 40 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Olmesartan medoxomil |
D01204
|
|
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
|
|
Vigabatrin tablet 500 mg (ANDA)
|
Edenbridge Pharmaceuticals LLC. |
Vigabatrin |
D00535
|
Pralatrexate injection 20 mg/mL (NDA AUTHORIZED GENERIC)
Pralatrexate injection 40 mg/2mL (NDA AUTHORIZED GENERIC)
|
Fresenius Kabi USA, LLC |
Pralatrexate |
D05589
|
|
Enalapril Maleate tablet 20 mg (ANDA)
|
ST. MARY'S MEDICAL PARK PHARMACY |
Enalapril Maleate |
D00621
|