Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088269
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SLO-BID THEOPHYLLINE 50MG CAPSULE, 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
01/31/1985 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
12/01/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/20/1990 SUPPL-29 Labeling

Label is not available on this site.

06/21/1990 SUPPL-28 Labeling

Label is not available on this site.

03/27/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/27/1990 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/04/1988 SUPPL-24 Labeling

Label is not available on this site.

06/07/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/07/1989 SUPPL-21 Labeling

Label is not available on this site.

06/07/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/19/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/19/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/07/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/13/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/18/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/18/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/18/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/18/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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