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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205074
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;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
12/01/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/27/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

ZOLMITRIPTAN

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 205074 ALEMBIC PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202560 GLENMARK GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202956 JUBILANT GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202890 ZYDUS PHARMS USA INC
ZOMIG-ZMT ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021231 ASTRAZENECA

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 205074 ALEMBIC PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202560 GLENMARK GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202956 JUBILANT GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202890 ZYDUS PHARMS USA INC
ZOMIG-ZMT ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021231 ASTRAZENECA
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