Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079242
Company: FRESENIUS KABI USA

Products on ANDA 079242

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	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/02/2009	ORIG-1	Approval			Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079242Orig1s000LBL.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/02/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 079242

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/079242Orig1s000LBL.pdf

Therapeutic Equivalents for ANDA 079242

SUMATRIPTAN SUCCINATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	202758	EUGIA PHARMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	079242	FRESENIUS KABI USA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	200183	HIKMA
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	213998	SOMERSET
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	079123	WEST-WARD PHARMS INT
SUMATRIPTAN SUCCINATE	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	078593	WOCKHARDT