Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021735
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERCONAZOLE TERCONAZOLE 0.8% CREAM;VAGINAL Prescription BX Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/01/2004 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21735lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21735ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021735s000_TerconazoleTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/30/2010 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021735s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021735s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/30/2010 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021735s004lbl.pdf
10/01/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21735lbl.pdf

TERCONAZOLE

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English