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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090314
Company: ONESOURCE SPECIALTY

Products on ANDA 090314

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	Discontinued	None	No	No
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	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 090314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2010	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
07/20/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/20/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/10/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/10/2015	SUPPL-2	Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090314

SUMATRIPTAN SUCCINATE

There are no Therapeutic Equivalents.

SUMATRIPTAN SUCCINATE (AUTOINJECTOR)

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	213518	ALEMBIC
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
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AB	090314	ONESOURCE SPECIALTY

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