Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073664
Company: HOSPIRA

Products on ANDA 073664

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 073664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1994	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/15/2016	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/05/1998	SUPPL-6	Labeling		Label is not available on this site.
02/05/1996	SUPPL-4	Labeling		Label is not available on this site.
02/05/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/05/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/05/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073664

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