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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076847
Company: DR REDDYS LABS INC

Products on ANDA 076847

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 076847

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				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2020	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/01/2020	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/14/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/14/2015	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/20/2012	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076847

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

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