An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202279
Company: JUBILANT GENERICS

Products on ANDA 202279

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2014	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
05/23/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202279

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

Top