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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020326
Company: MEDIMMUNE ONCOLOGY

Products on NDA 020326

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020326

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.

Labels for NDA 020326

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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