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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012209
Company: SPECTRUM PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOROURACIL FLUOROURACIL 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
FLUOROURACIL FLUOROURACIL 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/25/1962 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2016 SUPPL-40 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012209Orig1s040ltr.pdf
07/31/2000 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.
01/20/1999 SUPPL-38 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/12209-S038_Fluorouracil.pdf
09/15/1997 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.
05/05/1995 SUPPL-35 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
05/12/1994 SUPPL-33 Labeling

Label is not available on this site.
10/18/1991 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
05/20/1991 SUPPL-31 Labeling

Label is not available on this site.
03/20/1989 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
10/03/1988 SUPPL-29 Labeling

Label is not available on this site.
05/19/1988 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
10/21/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.
11/26/1986 SUPPL-26 Labeling

Label is not available on this site.
06/26/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
07/01/1986 SUPPL-23 Labeling

Label is not available on this site.
07/19/1984 SUPPL-21 Labeling

Label is not available on this site.
11/26/1986 SUPPL-20 Labeling

Label is not available on this site.
05/12/1983 SUPPL-19 Labeling

Label is not available on this site.
03/24/1982 SUPPL-18 Labeling

Label is not available on this site.
04/04/1980 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
11/08/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
01/10/1983 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
09/29/1978 SUPPL-14 Labeling

Label is not available on this site.
05/03/1977 SUPPL-13 Labeling

Label is not available on this site.
09/29/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/27/1976 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/27/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
07/22/1975 SUPPL-9 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
07/29/2016 SUPPL-40 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf
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