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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076933
Company: WATSON LABS

Products on ANDA 076933

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 076933

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/10/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076933TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/02/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/02/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/13/2012	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 076933

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	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	206019	IPCA LABS LTD
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	219036	VKT PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	200263	ZHEJIANG

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	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	206019	IPCA LABS LTD
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	219036	VKT PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	200263	ZHEJIANG

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	076847	DR REDDYS LABS INC
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	206019	IPCA LABS LTD
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	219036	VKT PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076933	WATSON LABS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	200263	ZHEJIANG

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