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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022377
Company: MERIDIAN MEDCL

Summary Review

Products on NDA 022377

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALSUMA	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022377

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022377s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022377s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377_alsuma_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022377Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf
04/15/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/05/2014	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022377Orig1s002,s004ltr.pdf

Labels for NDA 022377

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf
06/05/2014	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf
06/05/2014	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022377s002s004lbl.pdf
06/29/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022377s000lbl.pdf

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