BUTOCONAZOLE NITRATE از شرکت PADAGIS US

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
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BUTOCONAZOLE NITRATE از شرکت PADAGIS US

New Drug Application (NDA): 019881

Company: PADAGIS US

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
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

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
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