| Product |
Company |
Generic name |
KEGG DRUG |
|
Nystatin and Triamcinolone Acetonide cream 100000 [USP'U]/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
Nystatin and Triamcinolone Acetonide |
D10299
|
|
Tramadol Hydrochloride and Acetaminophen tablet, film coated 325 mg (ANDA)
|
REMEDYREPACK INC. |
Tramadol Hydrochloride and Acetaminophen |
D09999
|
|
Mirtazapine tablet, orally disintegrating 15 mg (ANDA)
|
Cardinal Health 107, LLC |
Mirtazapine |
D00563
|
|
Butorphanol Tartrate spray, metered 10 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Butorphanol Tartrate |
D00837
|
|
Amlodipine and Atorvastatin tablet, film coated 5 mg (ANDA)
|
Bryant Ranch Prepack |
Amlodipine and Atorvastatin |
D08488
|
|
Valacyclovir tablet 1000 mg (ANDA)
|
REMEDYREPACK INC. |
Valacyclovir |
D00398
|
|
CYANOCOBALAMIN injection, solution 1000 ug/mL (ANDA)
|
Somerset Therapeutics, LLC |
CYANOCOBALAMIN |
D00166
|
GABAPENTIN capsule 100 mg (ANDA)
GABAPENTIN capsule 300 mg (ANDA)
GABAPENTIN capsule 400 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
gabapentin |
D00332
|
MYCOPHENOLATE MOFETIL capsule 250 mg (ANDA)
MYCOPHENOLATE MOFETIL tablet 500 mg (ANDA)
|
CONCORD BIOTECH LIMITED |
mycophenolate mofetil |
D00752
|
|
Minocycline Hydrochloride tablet, film coated, extended release 65 mg (ANDA)
|
Bryant Ranch Prepack |
Minocycline Hydrochloride |
D00850
|
Marcaine injection, solution 2.5 mg/mL (NDA)
Marcaine injection, solution 5 mg/mL (NDA)
Marcaine injection, solution 7.5 mg/mL (NDA)
Marcaine with Epinephrine injection, solution 2.5 mg/mL (NDA)
Marcaine with Epinephrine injection, solution 5 mg/mL (NDA)
Marcaine injection, solution 250 mg/50mL (NDA)
Marcaine injection, solution 50 mg0mL (NDA)
Marcaine injection, solution 225 mg/30mL (NDA)
Marcaine injection, solution 75 mg/30mL (NDA)
Marcaine injection, solution 150 mg/30mL (NDA)
Marcaine injection, solution 25 mg0mL (NDA)
|
Hospira, Inc. |
BUPIVACAINE HYDROCHLORIDE |
D11569
|
Eletriptan hydrobromide tablet, film coated 20 mg (ANDA)
Eletriptan hydrobromide tablet, film coated 40 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Eletriptan hydrobromide |
D01973
|
topiramate tablet, film coated 25 mg (ANDA)
topiramate tablet, film coated 100 mg (ANDA)
|
Major Pharmaceuticals |
topiramate |
D00537
|
|
arformoterol tartrate solution 15 ug/2mL (ANDA)
|
Cipla USA Inc. |
arformoterol tartrate |
D02981
|
GABAPENTIN tablet 600 mg (ANDA)
GABAPENTIN tablet 800 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
Gabapentin |
D00332
|
Metoprolol succinate tablet, film coated, extended release 100 mg (ANDA)
Metoprolol succinate tablet, film coated, extended release 25 mg (ANDA)
Metoprolol succinate tablet, film coated, extended release 50 mg (ANDA)
Metoprolol succinate tablet, film coated, extended release 200 mg (ANDA)
|
AvPAK |
Metoprolol succinate |
D00635
|
|
Nitrofurantoin capsule 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Nitrofurantoin |
D00439
|
|
Minocycline Hydrochloride tablet, film coated, extended release 90 mg (ANDA)
|
Bryant Ranch Prepack |
Minocycline Hydrochloride |
D00850
|
Lisinopril tablet 10 mg (ANDA)
Lisinopril tablet 5 mg (ANDA)
Lisinopril tablet 20 mg (ANDA)
|
Cardinal Health 107, LLC |
Lisinopril |
D00362
|
METHYLPHENIDATE HYDROCHLORIDE tablet 5 mg (ANDA)
METHYLPHENIDATE HYDROCHLORIDE tablet 10 mg (ANDA)
METHYLPHENIDATE HYDROCHLORIDE tablet 20 mg (ANDA)
|
Camber Pharmaceutical Inc |
METHYLPHENIDATE HYDROCHLORIDE |
D01296
|
hydromorphone hydrochloride tablet, extended release 8 mg (ANDA)
hydromorphone hydrochloride tablet, extended release 12 mg (ANDA)
hydromorphone hydrochloride tablet, extended release 16 mg (ANDA)
hydromorphone hydrochloride tablet, extended release 32 mg (ANDA)
|
Padagis US LLC |
hydromorphone hydrochloride |
D00839
|
|
ELIQUIS tablet, film coated 5 mg (NDA)
|
REMEDYREPACK INC. |
apixaban |
D03213
|
|
Ciclopirox Olamine cream 7.7 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
ciclopirox olamine |
D01364
|
PREZISTA tablet, film coated 600 mg (NDA)
PREZISTA tablet, film coated 75 mg (NDA)
PREZISTA tablet, film coated 150 mg (NDA)
PREZISTA suspension 100 mg/mL (NDA)
PREZISTA tablet, film coated 800 mg (NDA)
|
Janssen Products LP |
darunavir |
D06478
|
|
NYSTATIN suspension 100000 [USP'U]/mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
NYSTATIN |
D00202
|
Bosentan tablet, coated 62.5 mg (ANDA)
Bosentan tablet, coated 125 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Bosentan |
D01227
|
|
sirolimus solution 1 mg/mL (ANDA)
|
Northstar Rx LLC |
sirolimus |
D00753
|
|
Irbesartan and Hydrochlorothiazide tablet 12.5 mg (ANDA)
|
REMEDYREPACK INC. |
Irbesartan and Hydrochlorothiazide |
D10249
|
Hydroxyzine Hydrochloride injection, solution 25 mg/mL (ANDA)
Hydroxyzine Hydrochloride injection, solution 50 mg/mL (ANDA)
|
American Regent, Inc. |
Hydroxyzine Hydrochloride |
D00672
|
Methadone Hydrochloride solution 5 mg/5mL (ANDA)
Methadone Hydrochloride solution 10 mg/5mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Methadone Hydrochloride |
D02102
|
|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel 50 mg/g (ANDA)
|
Encube Ethicals, Inc. |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
D10602
|
|
Atorvastatin calcium tablet, film coated 20 mg (ANDA)
|
REMEDYREPACK INC. |
Atorvastatin calcium |
D02258
|
|
Cephalexin for suspension 250 mg/5mL (ANDA)
|
Bryant Ranch Prepack |
Cephalexin |
D00906
|
|
Flecainide Acetate tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
Flecainide Acetate Tablet |
D00638
|
|
Rocuronium Bromide injection 10 mg/mL (ANDA)
|
Civica, Inc. |
Rocuronium Bromide |
D00765
|
|
Tramadol Hydrochloride tablet, coated 50 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Tramadol Hydrochloride |
D01355
|
Methadone Hydrochloride tablet 5 mg (ANDA)
Methadone Hydrochloride tablet 10 mg (ANDA)
|
Camber Pharmaceuticals, Inc |
Methadone Hydrochloride |
D02102
|
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)
|
Major Pharmaceuticals |
Enalapril maleate |
D00621
|
|
ziprasidone mesylate injection, powder, lyophilized, for solution 20 mg/mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
ziprasidone mesylate |
D02100
|
|
BACLOFEN tablet 5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
D00241
|