Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020574
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GYNE-LOTRIMIN 3 CLOTRIMAZOLE 2% 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
11/24/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20574lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20574ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-574_GyneLotrimin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/12/2010 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020574s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020574s006ltr.pdf
01/16/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/27/1999 SUPPL-1 Manufacturing (CMC)-Control

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-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020574s006lbl.pdf
11/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20574lbl.pdf

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