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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219194
Company: SOMERSET THERAPS LLC

Products on ANDA 219194

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	AN	No	No
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219194

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2025	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 219194

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	214177	CONBA USA
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	073664	HOSPIRA
ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	219194	SOMERSET THERAPS LLC

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	214177	CONBA USA
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	074037	HOSPIRA
ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION;INHALATION, ORAL	Prescription	No	AN	219194	SOMERSET THERAPS LLC

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