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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021200
Company: ALFASIGMA

Other Important Information from FDA

Products on NDA 021200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZELNORM	TEGASEROD MALEATE	EQ 2MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
ZELNORM	TEGASEROD MALEATE	EQ 6MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2002	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21200ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-200_Zelnorm.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2019	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021200Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021200Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/021200Orig1s015MultidisciplineR.pdf
03/01/2007	SUPPL-14	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021200s014ltr.pdf
06/02/2006	SUPPL-12	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021200s012LTR.pdf
05/25/2005	SUPPL-10	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021200s010ltr.pdf
04/15/2004	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021200s009ltr.pdf
04/21/2004	SUPPL-8	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf
04/21/2004	SUPPL-7	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf
06/15/2004	SUPPL-6	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scm006ltr.pdf
08/21/2004	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200s005ltr.pdf

Labels for NDA 021200

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2019	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021200Orig1s015lbl.pdf
03/01/2007	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf
08/21/2004	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf
06/15/2004	SUPPL-6	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf
04/21/2004	SUPPL-8	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf
04/21/2004	SUPPL-7	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf
04/15/2004	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf
07/24/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf

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