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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201779
Company: GLENMARK GENERICS
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 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
05/14/2013 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
01/13/2020 SUPPL-2 Labeling-Patient Package Insert, 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 PHARMS LTD
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 GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription No AB 204284 INVAGEN PHARMS
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
ZOMIG ZOLMITRIPTAN 2.5MG TABLET;ORAL Prescription Yes AB 020768 IPR

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 PHARMS LTD
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 GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET;ORAL Prescription No AB 204284 INVAGEN PHARMS
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
ZOMIG ZOLMITRIPTAN 5MG TABLET;ORAL Prescription Yes AB 020768 IPR
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