Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088253
Company: PHARM RES ASSOC

Products on ANDA 088253

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
T-PHYL	THEOPHYLLINE	200MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/1983	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
07/18/2002	SUPPL-22	Labeling		Label is not available on this site.
08/29/2000	SUPPL-21	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2000	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2000	SUPPL-19	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2000	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
08/29/2000	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
08/28/1996	SUPPL-15	Labeling		Label is not available on this site.
01/12/1995	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/08/1990	SUPPL-9	Bioequivalence		Label is not available on this site.
02/11/1992	SUPPL-7	Labeling		Label is not available on this site.
02/11/1992	SUPPL-6	Labeling		Label is not available on this site.