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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022404
Company: GALT PHARMS

Summary Review

Products on NDA 022404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORAVIG	MICONAZOLE	50MG	TABLET;BUCCAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022404lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022404s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404s000_oravig_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2020	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022404s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022404Orig1s005ltr.pdf
03/05/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022404s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022404Orig1s003ltr.pdf
04/08/2011	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022404s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022404s002ltr.pdf

Labels for NDA 022404

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/04/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022404s005lbl.pdf
03/05/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022404s003lbl.pdf
04/08/2011	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022404s002lbl.pdf
04/16/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022404lbl.pdf

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