Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018021
Company: LEDERLE

• Other Important Information from FDA

Products on NDA 018021

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASENDIN	AMOXAPINE	25MG	TABLET;ORAL	Discontinued	None	No	No
ASENDIN	AMOXAPINE	50MG	TABLET;ORAL	Discontinued	None	No	No
ASENDIN	AMOXAPINE	100MG	TABLET;ORAL	Discontinued	None	No	No
ASENDIN	AMOXAPINE	150MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018021

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/1980	ORIG-1	Approval	Type 1 - New Molecular Entity	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
09/25/2001	SUPPL-41	Labeling		Label is not available on this site.
03/04/1999	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
03/05/1999	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
04/06/2000	SUPPL-37	Labeling		Label is not available on this site.
05/14/1997	SUPPL-36	Manufacturing (CMC)-Control		Label is not available on this site.
02/06/1997	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
08/29/1996	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
04/06/2000	SUPPL-33	Labeling		Label is not available on this site.
05/03/1995	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
03/29/1994	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
01/03/1991	SUPPL-30	Manufacturing (CMC)-Control		Label is not available on this site.
04/06/2000	SUPPL-28	Labeling		Label is not available on this site.
02/18/1988	SUPPL-27	Labeling		Label is not available on this site.
07/30/1987	SUPPL-26	Labeling		Label is not available on this site.
06/04/1987	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/1988	SUPPL-24	Labeling		Label is not available on this site.
10/20/1986	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/1988	SUPPL-22	Labeling		Label is not available on this site.
02/18/1988	SUPPL-21	Unspecified		Label is not available on this site.
06/06/1985	SUPPL-19	Labeling		Label is not available on this site.
02/26/1985	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
12/13/1984	SUPPL-17	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/06/2000	SUPPL-16	Labeling		Label is not available on this site.
08/23/1983	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/1983	SUPPL-13	Labeling		Label is not available on this site.
10/04/1982	SUPPL-12	Labeling		Label is not available on this site.
05/04/1983	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/18/1982	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/12/1982	SUPPL-9	Labeling		Label is not available on this site.
12/22/1981	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/22/1981	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/22/1981	SUPPL-5	Labeling		Label is not available on this site.
02/17/1981	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/13/1981	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/09/1981	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/09/1981	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.