Albendazole
ANDA #208094 |
Albendazole |
Tablet; Oral |
ORIG-1 |
Actavis Elizabeth |
|
Approved |
Apokyn
NDA #021264 |
Apomorphine Hydrochloride |
Injectable; Subcutaneous |
SUPPL-16 |
Us Worldmeds |
Labeling |
Approved |
Apokyn
NDA #021264 |
Apomorphine Hydrochloride |
Injectable; Subcutaneous |
SUPPL-16 |
Us Worldmeds |
Labeling |
Approved |
Dactinomycin
ANDA #203999 |
Dactinomycin |
Injectable; Injection |
ORIG-1 |
X-Gen Pharms Inc |
|
Approved |
Dimethyl Fumarate
ANDA #210492 |
Dimethyl Fumarate |
Unknown |
ORIG-1 |
Sun Pharm Inds Ltd |
|
Tentative Approval |
Donepezil Hydrochloride
ANDA #090686 |
Donepezil Hydrochloride |
Tablet; Oral |
SUPPL-12 |
Torrent Pharms |
Labeling |
Approved |
Donepezil Hydrochloride
ANDA #203656 |
Donepezil Hydrochloride |
Tablet; Oral |
SUPPL-1 |
Unichem Labs Ltd |
Labeling |
Approved |
Donepezil Hydrochloride
ANDA #203656 |
Donepezil Hydrochloride |
Tablet; Oral |
SUPPL-1 |
Unichem Labs Ltd |
Labeling |
Approved |
Donepezil Hydrochloride
ANDA #203656 |
Donepezil Hydrochloride |
Tablet; Oral |
SUPPL-1 |
Unichem Labs Ltd |
Labeling |
Approved |
Donepezil Hydrochloride
ANDA #204609 |
Donepezil Hydrochloride |
Tablet; Oral |
SUPPL-2 |
Cadila Pharms Ltd |
Labeling |
Approved |
Donepezil Hydrochloride
ANDA #204609 |
Donepezil Hydrochloride |
Tablet; Oral |
SUPPL-2 |
Cadila Pharms Ltd |
Labeling |
Approved |
Faslodex
NDA #021344 |
Fulvestrant |
Injectable; Intramuscular |
SUPPL-39 |
Astrazeneca |
Labeling |
Approved |
Faslodex
NDA #021344 |
Fulvestrant |
Injectable; Intramuscular |
SUPPL-39 |
Astrazeneca |
Labeling |
Approved |
Fulvestrant
NDA #210326 |
Fulvestrant |
Injectable; Injection |
ORIG-1 |
Fresenius Kabi Usa |
Type 5 - New Formulation or New Manufacturer |
Approved |
Methylprednisolone Acetate
ANDA #210043 |
Methylprednisolone Acetate |
Injectable; Injection |
ORIG-1 |
Amneal Pharms Co |
|
Approved |
Solifenacin Succinate
ANDA #202551 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Watson Labs Inc |
|
Approved |
Solifenacin Succinate
ANDA #205483 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Ajanta Pharma Ltd |
|
Approved |
Solifenacin Succinate
ANDA #205575 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Alembic Pharms Ltd |
|
Approved |
Solifenacin Succinate
ANDA #209239 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Glenmark Pharms Inc |
|
Approved |
Solifenacin Succinate
ANDA #209333 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Qilu Pharm Co Ltd |
|
Approved |
Solifenacin Succinate
ANDA #209719 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Amneal Pharms Co |
|
Approved |
Solifenacin Succinate
ANDA #209818 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Breckenridge Pharm |
|
Approved |
Solifenacin Succinate
ANDA #209839 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Cipla |
|
Approved |
Solifenacin Succinate
ANDA #210224 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Alkem Labs Ltd |
|
Approved |
Solifenacin Succinate
ANDA #210281 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Jiangxi Boya Seehot |
|
Approved |
Solifenacin Succinate
ANDA #210582 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Airis Pharma Pvt Ltd |
|
Approved |
Solifenacin Succinate
ANDA #210688 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Msn Labs Pvt Ltd |
|
Approved |
Solifenacin Succinate
ANDA #211657 |
Solifenacin Succinate |
Tablet; Oral |
ORIG-1 |
Sciegen Pharms Inc |
|
Approved |