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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022055
Company: ALMIRALL

Products on NDA 022055

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALTABAX	RETAPAMULIN	1%	OINTMENT;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022055

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2007	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022055s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022055s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022055s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022055Orig1s007ltr.pdf
06/17/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/28/2010	SUPPL-4	Labeling, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022055s004ltr.pdf
08/01/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/21/2012	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022055Orig1s002ltr.pdf

Labels for NDA 022055

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022055s007lbl.pdf
12/21/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022055s002lbl.pdf
09/28/2010	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf
09/28/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022055s004lbl.pdf
04/12/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022055lbl.pdf

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