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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084731
Company: SCHERER RP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 200MG CAPSULE;ORAL Discontinued None No No
THEOPHYLLINE THEOPHYLLINE 100MG CAPSULE;ORAL Discontinued None No No
THEOPHYLLINE THEOPHYLLINE 250MG CAPSULE;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
10/07/1986 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
12/26/1990 SUPPL-1 Labeling

Label is not available on this site.

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