Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089131
Company: SCHERING

Products on ANDA 089131

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THEO-DUR	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089131

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/1986	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
01/10/2002	SUPPL-23	Labeling		Label is not available on this site.
08/18/1997	SUPPL-19	Labeling		Label is not available on this site.
08/18/1997	SUPPL-18	Labeling		Label is not available on this site.
07/17/1996	SUPPL-17	Labeling		Label is not available on this site.
11/21/1990	SUPPL-16	Labeling		Label is not available on this site.
11/21/1990	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/22/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/22/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/26/1989	SUPPL-11	Labeling		Label is not available on this site.
08/20/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.