Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019926
Company: EISAI INC

Products on NDA 019926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEXALEN	ALTRETAMINE	50MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019926

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.