An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020985
Company: VALEANT PHARMS NORTH

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.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2022	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	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
05/26/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020985Orig1s019lbl.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
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

Top