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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204674
Company: ALVOGEN

Products on ANDA 204674

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204674

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/11/2014	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 204674

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL; 10%
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	204674	ALVOGEN
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	072489	AM REGENT
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	073664	HOSPIRA

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