Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020326
Company: MEDIMMUNE ONCOLOGY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEUTREXIN TRIMETREXATE GLUCURONATE EQ 25MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
NEUTREXIN TRIMETREXATE GLUCURONATE EQ 200MG BASE/VIAL 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
12/17/1993 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
11/09/2005 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020326s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020326s015ltr.pdf
06/26/2002 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20326s011,013ltr.pdf
06/26/2002 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20326s011,013ltr.pdf
07/31/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1997 SUPPL-9 Labeling

Label is not available on this site.

08/28/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/05/1997 SUPPL-7 Labeling

Label is not available on this site.

01/21/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/13/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1995 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/09/1995 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/09/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/04/1994 SUPPL-1 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
11/09/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020326s015lbl.pdf
06/26/2002 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf
06/26/2002 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf

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