Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021789
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METROGEL METRONIDAZOLE 1% 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
06/30/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021789s000_MetrogelTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/12/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/04/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/19/2011 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021789s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021789Orig1s004.pdf
03/05/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021789s003ltr.pdf
08/29/2006 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

11/14/2005 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/19/2011 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf
03/05/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf
11/14/2005 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf
06/30/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789lbl.pdf

METROGEL

GEL;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METROGEL METRONIDAZOLE 1% GEL;TOPICAL Prescription Yes AB 021789 GALDERMA LABS LP
METRONIDAZOLE METRONIDAZOLE 1% GEL;TOPICAL Prescription No AB 204651 TARO
METRONIDAZOLE METRONIDAZOLE 1% GEL;TOPICAL Prescription No AB 090903 TOLMAR

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