Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020058
Company: IMMUNEX

Products on NDA 020058

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THIOPLEX	THIOTEPA	15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1994	ORIG-1	Approval	Type 3 - New Dosage Form	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
10/12/2000	SUPPL-10	Manufacturing (CMC)-Formulation	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020058Orig1s010.pdf
10/12/2000	SUPPL-9	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020058Orig1s009.pdf
03/02/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/08/1999	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/16/2000	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/22/1999	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/26/1997	SUPPL-4	Labeling		Label is not available on this site.
09/26/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/26/1997	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.