Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208826
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription AB No No
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

TETRABENAZINE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 207682 APICORE US
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 208826 BIONPHARMA INC
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 209284 DR REDDYS
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 204574 HETERO LABS LTD V
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 206129 SUN PHARM
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 209739 WEST-WARD PHARMS INT
XENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription Yes AB 021894 VALEANT PHARMS NORTH

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 206686 ACTAVIS LABS FL INC
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 207682 APICORE US
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 208826 BIONPHARMA INC
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 209284 DR REDDYS
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 204574 HETERO LABS LTD V
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 206129 SUN PHARM
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 209739 WEST-WARD PHARMS INT
XENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription Yes AB 021894 VALEANT PHARMS NORTH

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English