Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020531
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METROCREAM METRONIDAZOLE 0.75% CREAM;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
09/20/1995 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
08/30/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METROCREAM

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

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