Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020901
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METROLOTION METRONIDAZOLE 0.75% LOTION;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
11/24/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20901lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20901ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20901.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/07/2015 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

05/11/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20901slr002ltr.pdf
12/06/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf
11/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20901lbl.pdf

METROLOTION

LOTION;TOPICAL; 0.75%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METROLOTION METRONIDAZOLE 0.75% LOTION;TOPICAL Prescription Yes AB 020901 GALDERMA LABS LP
METRONIDAZOLE METRONIDAZOLE 0.75% LOTION;TOPICAL Prescription No AB 077197 FOUGERA PHARMS

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