Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020985
Company: VALEANT PHARMS NORTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARAC FLUOROURACIL 0.5% CREAM;TOPICAL Prescription AB Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

CARAC

CREAM;TOPICAL; 0.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARAC FLUOROURACIL 0.5% CREAM;TOPICAL Prescription Yes AB 020985 VALEANT PHARMS NORTH
FLUOROURACIL FLUOROURACIL 0.5% CREAM;TOPICAL Prescription No AB 203122 MYLAN PHARMS INC

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