Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089540
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SLO-BID THEOPHYLLINE 125MG 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
05/10/1989 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-12 Manufacturing (CMC)

Label is not available on this site.

03/19/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/20/1990 SUPPL-7 Labeling

Label is not available on this site.

08/10/1990 SUPPL-6 Labeling

Label is not available on this site.

05/30/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/30/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/30/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/27/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/27/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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