Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090495
Company: DR REDDYS

Products on ANDA 090495

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090495

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2014	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2014/090495Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2022	SUPPL-15	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/06/2022	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/06/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/06/2022	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/06/2016	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/06/2016	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/07/2015	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/29/2014	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090495

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS; EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX STATDOSE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AB	020080	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AB	090495	DR REDDYS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AB	090358	SUN PHARM