Drugs@FDA: FDA Approved Drug Products

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

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