Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018067
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CINOBAC CINOXACIN 250MG CAPSULE;ORAL Discontinued None No No
CINOBAC CINOXACIN 500MG CAPSULE;ORAL Discontinued None No 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
06/13/1980 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
08/24/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/2000 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/2002 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18067slr029ltr.pdf
08/04/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/04/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1998 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/21/1996 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1996 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1992 SUPPL-21 Labeling

Label is not available on this site.

08/11/1992 SUPPL-20 Labeling

Label is not available on this site.

08/21/1989 SUPPL-19 Labeling

Label is not available on this site.

12/02/1988 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-16 Labeling

Label is not available on this site.

06/18/1987 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/11/1987 SUPPL-13 Labeling

Label is not available on this site.

11/25/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1987 SUPPL-11 Labeling

Label is not available on this site.

11/22/1985 SUPPL-10 Labeling

Label is not available on this site.

10/16/1985 SUPPL-9 Labeling

Label is not available on this site.

12/07/2007 SUPPL-8 Labeling

Label is not available on this site.

12/07/2007 SUPPL-7 Labeling

Label is not available on this site.

05/31/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-4 Labeling

Label is not available on this site.

11/03/1981 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/13/1981 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/14/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2002 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf

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