Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016988
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROPLEX FLUOROURACIL 1% CREAM;TOPICAL Prescription None 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
08/06/1971 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2016 SUPPL-30 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016988Orig1s030ltr.pdf
01/29/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/01/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/18/2002 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/30/1997 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1987 SUPPL-20 Labeling

Label is not available on this site.

01/12/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/07/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1980 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/17/1978 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/01/1977 SUPPL-14 Labeling

Label is not available on this site.

03/02/1977 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/06/1976 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1976 SUPPL-10 Labeling

Label is not available on this site.

12/24/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1974 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf
07/25/2016 SUPPL-30 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016988s030lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English