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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205074
Company: ALEMBIC

Products on ANDA 205074

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205074

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.

Therapeutic Equivalents for ANDA 205074

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
ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	202560	GLENMARK PHARMS LTD
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

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
ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	202560	GLENMARK PHARMS LTD
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

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