Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076408
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 0.75% CREAM;TOPICAL Prescription AB 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
05/28/2004 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76408ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076408_ORIGINAL APPROVAL_PACKAGE.pdf

METRONIDAZOLE

CREAM;TOPICAL; 0.75%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METROCREAM METRONIDAZOLE 0.75% CREAM;TOPICAL Prescription Yes AB 020531 GALDERMA LABS LP
METRONIDAZOLE METRONIDAZOLE 0.75% CREAM;TOPICAL Prescription No AB 077549 COSETTE
METRONIDAZOLE METRONIDAZOLE 0.75% CREAM;TOPICAL Prescription No AB 076408 FOUGERA PHARMS

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