Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019881
Company: PADAGIS US

Products on NDA 019881

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTOCONAZOLE NITRATE	BUTOCONAZOLE NITRATE	2%	CREAM;VAGINAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019881

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/1997	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
08/10/2012	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/24/2003	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19881slr009_gynazole_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19881slr009ltr.pdf
08/02/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/01/2000	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/12/2000	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/30/2003	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19881slr002ltr.pdf

Labels for NDA 019881

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/24/2003	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19881slr009_gynazole_lbl.pdf
04/30/2003	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019881s002lbl.pdf