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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020625
Company: CHATTEM SANOFI

Products on NDA 020625

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALLEGRA	FEXOFENADINE HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020625Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2003	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf
07/11/2001	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf
05/12/2003	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf
01/06/2000	SUPPL-9	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s009_ALLEGRA TABLETS.pdf
01/21/2000	SUPPL-8	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s008_ALLEGRA_TABLETS.pdf
12/22/1998	SUPPL-7	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s007_ALLEGRA TABLETS.pdf
07/06/1998	SUPPL-6	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s006_ALLEGRA TABLETS.pdf
01/29/1998	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/28/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/16/1996	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020625

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2003	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf
05/12/2003	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf
07/25/1996	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf

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