Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086107
Company: 3M
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOLAIR THEOPHYLLINE 80MG/15ML SOLUTION;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
03/26/1979 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
09/20/1996 SUPPL-8 Labeling

Label is not available on this site.

06/12/1991 SUPPL-6 Labeling

Label is not available on this site.

06/18/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/18/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/18/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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