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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021145
Company: ABBVIE

Products on NDA 021145

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANIQA	EFLORNITHINE HYDROCHLORIDE	13.9%	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021145

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21145lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21145ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21145_Vaniga.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/29/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/30/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/22/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/05/2001	SUPPL-5	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S005_VANIQA CREAM.pdf
06/29/2001	SUPPL-3	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S003_VANIQA CREAM.pdf
06/25/2001	SUPPL-2	Manufacturing (CMC)-Packaging	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021145_S002_VANIQA CREAM.pdf
12/15/2000	SUPPL-1	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021145_S001_VANIQA CREAM.pdf

Labels for NDA 021145

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21145lbl.pdf

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