Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204041
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/20/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/03/2019 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
ZOLMITRIPTAN
TABLET;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 204041 | AJANTA PHARMA LTD |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 204232 | ALEMBIC |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 206973 | APPCO |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207021 | AUROBINDO PHARMA |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 201779 | GLENMARK PHARMS LTD |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202279 | JUBILANT GENERICS |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 203726 | ORBION PHARMS |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207867 | PLD ACQUISITIONS LLC |
ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 203019 | ZYDUS PHARMS |
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 204041 | AJANTA PHARMA LTD |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 204232 | ALEMBIC |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 206973 | APPCO |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 207021 | AUROBINDO PHARMA |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 201779 | GLENMARK PHARMS LTD |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 202279 | JUBILANT GENERICS |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 203726 | ORBION PHARMS |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 207867 | PLD ACQUISITIONS LLC |
ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET;ORAL | Prescription | No | AB | 203019 | ZYDUS PHARMS |