Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050521
Company: LILLY
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CECLOR CEFACLOR EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
CECLOR CEFACLOR EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
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.

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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