Product |
Company |
Generic name |
KEGG DRUG |
Sevelamer carbonate tablet, film coated 800 mg (ANDA)
|
Exelan Pharmaceuticals Inc.
|
SEVELAMER CARBONATE
|
D06642
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
KVK-TECH, Inc.
|
Cyclobenzaprine Hydrochloride
|
D00772
|
TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) solution .275 g000mL (NDA)
|
Terumo Corporation
|
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
|
|
TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) solution .275 g000mL (NDA)
|
Terumo Corporation
|
Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1)
|
|
Pramosone lotion 10 mg/mL (ANDA)
|
Sebela Pharmaceuticals Inc.
|
hydrocortisone acetate and pramoxine hydrochloride
|
D11657
|
Pindolol tablet 5 mg (ANDA)
Pindolol tablet 10 mg (ANDA)
|
Nostrum Laboratories, Inc.
|
Pindolol
|
D00513
|
Misoprostol tablet 200 ug (ANDA)
|
Pharmacist Pharmaceutical, LLC
|
Misoprostol
|
D00419
|
Desoximetasone cream 2.5 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
|
Desoximetasone
|
D03697
|
Nitrogen gas 990 mL/L (NDA)
|
Air Products and Chemicals, Inc.
|
Nitrogen
|
D00083
|
Gliadel wafer 7.7 mg (NDA)
|
Arbor Pharmaceuticals
|
carmustine
|
D00254
|
RIDAURA capsule 3 mg (NDA)
|
Sebela Pharmaceuticals Inc.
|
auranofin
|
D00237
|
Motofen tablet .025 mg (NDA)
|
Sebela Pharmaceuticals Inc.
|
difenoxin and atropine sulfate
|
D02128
|
Trihexyphenidyl Hydrochloride tablet 2 mg (ANDA)
Trihexyphenidyl Hydrochloride tablet 5 mg (ANDA)
|
Bionpharma Inc.
|
Trihexyphenidyl Hydrochloride
|
D00787
|
Progesterone injection 50 mg (ANDA)
|
West-Ward Pharmaceuticals Corp
|
Progesterone
|
D00066
|
Ondansetron injection 2 mg/mL (ANDA)
|
West-Ward Pharmaceuticals Corp
|
Ondansetron
|
D00678
|
Oxytocin injection 10 [USP'U]/mL (ANDA)
|
West-Ward Pharmaceuticals Corp
|
Oxytocin
|
D00089
|
Glycopyrrolate tablet 1 mg (ANDA)
Glycopyrrolate tablet 2 mg (ANDA)
|
Par Pharmaceutical, Inc.
|
glycopyrrolate
|
D00540
|
Azelastine Hydrochloride spray, metered 137 ug (ANDA)
|
Sun Pharmaceutical Industries, Inc.
|
Azelastine Hydrochloride
|
D00659
|
ELIXOPHYLLIN liquid 80 mg5mL (ANDA)
|
Nostrum Laboratories, Inc.
|
THEOPHYLLINE ANHYDROUS
|
D00371
|
Nicardipine Hydrochloride injection 2.5 mg/mL (NDA)
|
West-Ward Pharmaceuticals Corp
|
Nicardipine Hydrochloride
|
D00617
|
Paricalcitol injection 5 ug/mL (NDA)
Paricalcitol injection 2 ug/mL (NDA)
|
West-Ward Pharmaceuticals Corp
|
Paricalcitol
|
D00930
|
Palonosetron Hydrochloride injection .25 mg/2mL (NDA)
|
West-Ward Pharmaceuticals Corp
|
Palonosetron Hydrochloride
|
D05343
|
promethazine hydrochloride and codeine phosphate solution 10 mg/5mL (ANDA)
|
Nostrum Laboratories, Inc.
|
promethazine hydrochloride and codeine phosphate
|
D11852
|
Labetalol Hydrochloride injection 5 mg/mL (ANDA)
|
West-Ward Pharmaceuticals Corp
|
Labetalol Hydrochloride
|
D00600
|
Labetalol Hydrochloride injection 5 mg/mL (ANDA)
|
West-Ward Pharmaceuticals Corp
|
Labetalol Hydrochloride
|
D00600
|
Finasteride tablet 1 mg (ANDA)
|
Cipla USA Inc.
|
Finasteride
|
D00321
|
Enalapril Maleate tablet 2.5 mg (ANDA)
Enalapril Maleate tablet 5 mg (ANDA)
Enalapril Maleate tablet 10 mg (ANDA)
Enalapril Maleate tablet 20 mg (ANDA)
|
Northstar RxLLC
|
enalapril maleate
|
D00621
|
Clotrimazole cream 10 mg/g (ANDA)
|
Glenmark Pharmaceuticals Inc., USA
|
Clotrimazole
|
D00282
|
ERY-TAB tablet, delayed release 250 mg (ANDA)
ERY-TAB tablet, delayed release 333 mg (ANDA)
ERY-TAB tablet, delayed release 500 mg (ANDA)
|
Arbor Pharmaceuticals, Inc.
|
Erythromycin
|
D00140
|
Riomet solution 500 mg/5mL (NDA)
|
Sun Pharmaceutical Industries, Inc.
|
Metformin Hydrochloride
|
D00944
|
Erythrocin Stearate tablet, film coated 250 mg (ANDA)
|
Arbor Pharmaceuticals, Inc.
|
ERYTHROMYCIN STEARATE
|
D02184
|
Diclofenac Sodium solution/ drops 1 mg/mL (ANDA)
|
Rising Pharmaceuticals, Inc.
|
Diclofenac Sodium
|
D00904
|
levocetirizine dihydrochloride tablet, coated 5 mg (ANDA)
|
Dr.Reddy's laboratories Ltd.
|
levocetirizine dihydrochloride
|
D08118
|
Lamotrigine tablet, chewable 5 mg (ANDA)
Lamotrigine tablet, chewable 25 mg (ANDA)
|
Dr.Reddy's Laboratories Limited
|
Lamotrigine
|
D00354
|
Olanzapine tablet, film coated 2.5 mg (ANDA)
Olanzapine tablet, film coated 5 mg (ANDA)
Olanzapine tablet, film coated 10 mg (ANDA)
Olanzapine tablet, film coated 20 mg (ANDA)
|
NCS HealthCare of KY, Inc dba Vangard Labs
|
Olanzapine
|
D00454
|
Erythromycin tablet, film coated 250 mg (ANDA)
Erythromycin tablet, film coated 500 mg (ANDA)
|
Arbor Pharmaceuticals, Inc.
|
Erythromycin
|
D00140
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
NCS HealthCare of KY, Inc dba Vangard Labs
|
Sevelamer Carbonate
|
D06642
|
Levetiracetam tablet 1000 mg (ANDA)
|
Dr. Reddy's Laboratories Limited
|
Levetiracetam
|
D00709
|
Doxycycline Hyclate tablet 100 mg (ANDA)
|
Novel Laboratories, Inc.
|
Doxycycline Hyclate
|
D02129
|
Isoplate solution .03 g00mL (NDA)
|
Terumo BCT Ltd.
|
SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC
|
|