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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083921
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELIXOPHYLLIN THEOPHYLLINE 200MG 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
07/31/1984 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
02/17/1998 SUPPL-7 Labeling

Label is not available on this site.

05/15/1990 SUPPL-5 Labeling

Label is not available on this site.

12/29/1988 SUPPL-4 Labeling

Label is not available on this site.

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