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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020985
Company: EXTROVIS

Products on NDA 020985

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARAC	FLUOROURACIL	0.5%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020985

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/27/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20985lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20985ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/carac_20985.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2025	SUPPL-21	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020985Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020985Orig1s021ltr.pdf
05/26/2022	SUPPL-19	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020985Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020985Orig1s019ltr.pdf
04/29/2015	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/20/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/16/2003	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20985slr004_carac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20985slr004ltr.pdf
11/15/2002	SUPPL-3	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
07/02/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/29/2001	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020985

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2025	SUPPL-21	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020985Orig1s021lbl.pdf
05/26/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020985Orig1s019lbl.pdf
05/26/2022	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020985Orig1s019lbl.pdf
05/26/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020985Orig1s019lbl.pdf
12/16/2003	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20985slr004_carac_lbl.pdf
10/27/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20985lbl.pdf

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