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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219444
Company: BRECKENRIDGE

Products on ANDA 219444

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219444

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219444

DEHYDRATED ALCOHOL

SOLUTION;INTRA-ARTERIAL; 99% (5ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABLYSINOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	Yes	AP	207987	BPI LABS
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	217845	ACCORD HLTHCARE
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	219444	BRECKENRIDGE
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	219569	INGENUS PHARMS LLC
DEHYDRATED ALCOHOL	DEHYDRATED ALCOHOL	99% (5ML)	SOLUTION;INTRA-ARTERIAL	Prescription	No	AP	219400	XGEN PHARMS

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