Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087863
Company: WARNER CHILCOTT LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHOLEDYL SA OXTRIPHYLLINE 400MG TABLET, EXTENDED RELEASE;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
05/24/1983 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
06/08/1999 SUPPL-20 Labeling

Label is not available on this site.

06/08/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/08/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/24/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/19/1993 SUPPL-12 Labeling

Label is not available on this site.

08/12/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/21/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/21/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/21/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/17/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/17/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/05/1991 SUPPL-1 Labeling

Label is not available on this site.

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