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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211558
Company: B BRAUN MEDICAL

Products on ANDA 211558

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TROMETHAMINE	TROMETHAMINE	18GM/500ML (3.6GM/100ML)	SOLUTION;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211558

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211558

TROMETHAMINE

SOLUTION;INJECTION; 18GM/500ML (3.6GM/100ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
THAM	TROMETHAMINE	18GM/500ML (3.6GM/100ML)	SOLUTION;INJECTION	Prescription	Yes	AP	013025	HOSPIRA
TROMETHAMINE	TROMETHAMINE	18GM/500ML (3.6GM/100ML)	SOLUTION;INJECTION	Prescription	No	AP	211558	B BRAUN MEDICAL
TROMETHAMINE	TROMETHAMINE	18GM/500ML (3.6GM/100ML)	SOLUTION;INJECTION	Prescription	No	AP	213116	MILLA PHARMS

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