Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087892
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SLO-BID THEOPHYLLINE 100MG 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-39 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/20/1990 SUPPL-34 Labeling

Label is not available on this site.

09/16/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

09/16/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/16/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/27/1990 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/27/1990 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

06/07/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/07/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/04/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/07/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/19/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/31/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/31/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/31/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/09/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/23/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/24/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/31/1986 SUPPL-6 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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