Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086399
Company: MEDICIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOLAIR THEOPHYLLINE 125MG TABLET;ORAL Discontinued None No No
THEOLAIR THEOPHYLLINE 250MG TABLET;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
05/30/1980 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
10/20/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/20/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-13 Labeling

Label is not available on this site.

07/08/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/18/1990 SUPPL-10 Labeling

Label is not available on this site.

06/22/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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