Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018052
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GYNE-LOTRIMIN CLOTRIMAZOLE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;VAGINAL Discontinued None Yes No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
11/08/1978 ORIG-1 Approval Type 3 - New Dosage Form 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
04/12/2010 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018052s032ltr.pdf
01/16/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/2000 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/2000 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/11/1998 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/1993 SUPPL-24 Efficacy-New Indication

Label is not available on this site.

04/15/1993 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/1992 SUPPL-22 Labeling

Label is not available on this site.

04/21/1993 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/12/1992 SUPPL-20 Labeling

Label is not available on this site.

04/14/1992 SUPPL-19 Labeling

Label is not available on this site.

09/22/1993 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/23/1992 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1990 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/04/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1990 SUPPL-12 Efficacy-Rx To OTC Switch

Label is not available on this site.

06/18/1987 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1985 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/17/1981 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1981 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1986 SUPPL-4 Labeling

Label is not available on this site.

03/27/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1980 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/27/1979 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/12/2010 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018052Orig1s032lbl.pdf

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