Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019737
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METROGEL METRONIDAZOLE 0.75% GEL;TOPICAL Prescription AB 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
11/22/1988 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2002 SUPPL-7 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19737s007ltr.pdf
08/21/1995 SUPPL-6 Labeling

Label is not available on this site.

03/24/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/20/1989 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/19/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/02/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METROGEL

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