Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086760
Company: PHARM RES ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHYLLOCONTIN AMINOPHYLLINE 225MG 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
11/21/1979 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
03/03/1997 SUPPL-12 Labeling

Label is not available on this site.

03/06/1996 SUPPL-11 Labeling

Label is not available on this site.

08/16/1991 SUPPL-6 Labeling

Label is not available on this site.

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