Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085187
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SLO-PHYLLIN THEOPHYLLINE 80MG/15ML SYRUP;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
05/15/1979 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
04/29/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/05/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/04/1993 SUPPL-23 Labeling

Label is not available on this site.

03/04/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/13/1990 SUPPL-21 Labeling

Label is not available on this site.

09/01/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/01/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/11/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/08/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/08/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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