Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011683
Company: IMMUNEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOTEPA THIOTEPA 15MG/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
03/09/1959 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/1993 SUPPL-23 Labeling

Label is not available on this site.

12/18/1990 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1986 SUPPL-16 Labeling

Label is not available on this site.

02/14/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/16/1978 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/21/1978 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/10/1978 SUPPL-9 Unspecified

Label is not available on this site.

09/15/1975 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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