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): 200263
Company: COREPHARMA

Products on ANDA 200263

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/25/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200263

SUMATRIPTAN SUCCINATE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	020132	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078327	AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	200263	COREPHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	077744	MYLAN
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078284	ORBION PHARMS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078295	SUN PHARM INDS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	020132	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078327	AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	200263	COREPHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	077744	MYLAN
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078284	ORBION PHARMS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078295	SUN PHARM INDS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	020132	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078327	AUROBINDO PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	200263	COREPHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	077744	MYLAN
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078284	ORBION PHARMS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078295	SUN PHARM INDS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS

Top