Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091156
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 80MG/15ML SOLUTION;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/13/2011 ORIG-1 Approval

Label is not available on this site.

THEOPHYLLINE

SOLUTION;ORAL; 80MG/15ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOPHYLLINE THEOPHYLLINE 80MG/15ML SOLUTION;ORAL Prescription No AA 091156 LANNETT CO INC
THEOPHYLLINE THEOPHYLLINE 80MG/15ML SOLUTION;ORAL Prescription No AA 091586 TRIS PHARMA INC

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