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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206344
Company: PHARM ASSOC

Products on ANDA 206344

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206344

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206344

THEOPHYLLINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELIXOPHYLLIN	THEOPHYLLINE	80MG/15ML	SOLUTION, ELIXIR;ORAL	Prescription	Yes	AA	085186	NOSTRUM LABS INC
THEOPHYLLINE	THEOPHYLLINE	80MG/15ML	SOLUTION, ELIXIR;ORAL	Prescription	No	AA	206344	PHARM ASSOC

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