Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019926
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEXALEN ALTRETAMINE 50MG CAPSULE;ORAL 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
12/26/1990 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
08/29/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/09/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/28/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/11/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/11/1995 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1995 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/26/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/10/1993 SUPPL-10 Labeling

Label is not available on this site.

05/29/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1992 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/20/1991 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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