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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020922
Company: ALMIRALL

Products on NDA 020922

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLAGE	MEQUINOL; TRETINOIN	2%;0.01%	SOLUTION;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020922

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/1999	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20922ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-922_Solage.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020922s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020922Orig1s007ltr.pdf
12/30/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020922s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020922s006ltr.pdf
04/25/2007	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020922s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020922s003ltr.pdf

Labels for NDA 020922

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/02/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020922s007lbl.pdf
12/30/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020922s006lbl.pdf
04/25/2007	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020922s003lbl.pdf
12/10/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf

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