Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018021
Company: LEDERLE
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
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.

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