Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088900
Company: COPLEY PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE 25MG 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
10/08/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

04/02/2001 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/10/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/10/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/26/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/12/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/12/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/10/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/07/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/07/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/07/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/07/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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