Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085202
Company: SANOFI AVENTIS US

Products on ANDA 085202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SLO-PHYLLIN	THEOPHYLLINE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/1979	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-24	Manufacturing (CMC)		Label is not available on this site.
11/27/1990	SUPPL-21	Labeling		Label is not available on this site.
07/26/1990	SUPPL-20	Labeling		Label is not available on this site.
06/18/1990	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/18/1990	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/01/1985	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/30/1984	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/10/1984	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/26/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/03/1983	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/15/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/15/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/15/1982	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/15/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.