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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091586
Company: TRIS PHARMA INC

Products on ANDA 091586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2012	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091586

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	CHARTWELL MOLECULAR
THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	SOLUTION;ORAL	Prescription	No	AA	091586	TRIS PHARMA INC

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