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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021789
Company: GALDERMA LABS LP

Products on NDA 021789

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METROGEL	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021789

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2023	SUPPL-13	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021789s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021789Orig1s013ltr.pdf
03/16/2022	SUPPL-10	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021789 Orig1s009, s010ltr.pdf
03/16/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021789 Orig1s009, s010ltr.pdf
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

Labels for NDA 021789

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2023	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021789s013lbl.pdf
11/22/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021789s013lbl.pdf
03/16/2022	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf
03/16/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021789s009s010lbl.pdf
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

Therapeutic Equivalents for NDA 021789

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	212646	ALEMBIC
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	218941	AUROBINDO PHARMA LTD
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	216692	COSETTE PHARMS NC
METRONIDAZOLE	METRONIDAZOLE	1%	GEL;TOPICAL	Prescription	No	AB	204651	TARO

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