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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203853
Company: ALVOGEN

Products on ANDA 203853

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203853

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2012	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 203853

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL; 20%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	203853	ALVOGEN
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	072547	AM REGENT
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	074037	HOSPIRA

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