Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206129
Company: SUN PHARM
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/04/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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 | 213621 | AJANTA PHARMA LTD |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 206093 | APOTEX |
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 | 210544 | LUPIN LTD |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 207682 | MYLAN |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 213316 | PIRAMAL HLTHCARE UK |
TETRABENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 206129 | SUN PHARM |
XENAZINE | TETRABENAZINE | 12.5MG | TABLET;ORAL | Prescription | Yes | AB | 021894 | BAUSCH |
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 | 213621 | AJANTA PHARMA LTD |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 206093 | APOTEX |
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 | 210544 | LUPIN LTD |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 207682 | MYLAN |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 213316 | PIRAMAL HLTHCARE UK |
TETRABENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | No | AB | 206129 | SUN PHARM |
XENAZINE | TETRABENAZINE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 021894 | BAUSCH |
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