Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072547
Company: AM REGENT

Products on ANDA 072547

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072547

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/1995	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
04/12/2001	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/30/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/23/1998	SUPPL-3	Labeling		Label is not available on this site.
11/04/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/13/1998	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072547

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