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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213518
Company: ALEMBIC

Products on ANDA 213518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	AB	No	No
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 213518

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213518

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS; EQ 4MG BASE/0.5ML (EQ 8MG 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 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AB	020080	GLAXOSMITHKLINE
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AB	213518	ALEMBIC

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

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