Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206129
Company: SUN PHARM

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
08/17/2015 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206129Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206129Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/17/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206129Orig1s000lbl.pdf

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 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 209739 HIKMA
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 207682 MYLAN
TETRABENAZINE TETRABENAZINE 12.5MG TABLET;ORAL Prescription No AB 206129 SUN PHARM
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 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 209739 HIKMA
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 207682 MYLAN
TETRABENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription No AB 206129 SUN PHARM
XENAZINE TETRABENAZINE 25MG TABLET;ORAL Prescription Yes AB 021894 VALEANT PHARMS NORTH

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