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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020901
Company: GALDERMA LABS LP

Products on NDA 020901

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METROLOTION	METRONIDAZOLE	0.75%	LOTION;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020901

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.

Labels for NDA 020901

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

Therapeutic Equivalents for NDA 020901

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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