Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040023
Company: TEVA PARENTERAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADRUCIL FLUOROURACIL 50MG/ML INJECTABLE;INJECTION Discontinued None No 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
10/18/1991 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/1999 SUPPL-6 Labeling

Label is not available on this site.

09/12/1997 SUPPL-4 Labeling

Label is not available on this site.

11/04/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/10/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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