Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077018
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;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
06/06/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077018s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

METRONIDAZOLE

GEL;TOPICAL; 0.75%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METROGEL METRONIDAZOLE 0.75% GEL;TOPICAL Prescription Yes AB 019737 GALDERMA LABS LP
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;TOPICAL Prescription No AB 078178 COSETTE
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;TOPICAL Prescription No AB 077018 FOUGERA PHARMS
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;TOPICAL Prescription No AB 077819 TARO
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;TOPICAL Prescription No AB 077547 TOLMAR

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