Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085187
Company: SANOFI AVENTIS US

Products on ANDA 085187

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085187

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.