Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020208
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METROGEL-VAGINAL METRONIDAZOLE 0.75% GEL;VAGINAL 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
08/17/1992 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
04/17/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/28/1997 SUPPL-7 Labeling

Label is not available on this site.

05/16/1997 SUPPL-6 Efficacy-New Dosing Regimen

Label is not available on this site.

02/07/1995 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/30/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/06/1995 SUPPL-3 Labeling

Label is not available on this site.

07/26/1993 SUPPL-2 Labeling

Label is not available on this site.

03/17/1993 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

METROGEL-VAGINAL

GEL;VAGINAL; 0.75%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METROGEL-VAGINAL METRONIDAZOLE 0.75% GEL;VAGINAL Prescription Yes AB 020208 BAUSCH
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;VAGINAL Prescription No AB 211786 PERRIGO UK FINCO
METRONIDAZOLE METRONIDAZOLE 0.75% GEL;VAGINAL Prescription No AB 077264 TOLMAR

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