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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021902
Company: ANI PHARMS

Products on NDA 021902

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VEREGEN	SINECATECHINS	15%	OINTMENT;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021902

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2006	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2018	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021902Orig1s033Ltr.pdf
07/08/2016	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
07/06/2015	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
05/09/2013	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
05/31/2013	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
03/01/2013	SUPPL-26	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf
11/19/2012	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf
09/18/2008	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021902s017ltr.pdf
02/13/2008	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
06/27/2007	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/19/2007	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf
06/01/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf

Labels for NDA 021902

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2018	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf
11/19/2012	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf
09/18/2008	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf
12/19/2007	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf
06/01/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf
10/31/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf

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