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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050521
Company: LILLY

Products on NDA 050521

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CECLOR	CEFACLOR	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
CECLOR	CEFACLOR	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/1979	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2004	SUPPL-27	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50521slr027,50522slr027ltr.pdf
03/03/2003	SUPPL-26	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50521slr026,50522slr024ltr.pdf
04/27/2000	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2000	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
07/29/1999	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/18/1998	SUPPL-22	Labeling		Label is not available on this site.
02/02/1998	SUPPL-21	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050521s021_ceclor.pdf
09/30/1996	SUPPL-18	Labeling		Label is not available on this site.
03/06/1996	SUPPL-17	Labeling		Label is not available on this site.
04/13/1995	SUPPL-16	Labeling		Label is not available on this site.
05/28/1993	SUPPL-15	Labeling		Label is not available on this site.
11/08/1991	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
03/10/1994	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1991	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/01/1996	SUPPL-11	Labeling		Label is not available on this site.
05/01/1996	SUPPL-10	Labeling		Label is not available on this site.

Labels for NDA 050521

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2004	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf

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