Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019083
Company: B BRAUN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 40MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 80MG/100ML INJECTABLE;INJECTION Discontinued None No No
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER THEOPHYLLINE 160MG/100ML INJECTABLE;INJECTION 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
11/07/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/1990 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/18/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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