Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020058
Company: IMMUNEX
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THIOPLEX THIOTEPA 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
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.

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