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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215488
Company: ONESOURCE SPECIALTY

Products on ANDA 215488

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHOHEXITAL SODIUM	METHOHEXITAL SODIUM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215488

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215488

METHOHEXITAL SODIUM

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BREVITAL SODIUM	METHOHEXITAL SODIUM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	011559	ENDO OPERATIONS
METHOHEXITAL SODIUM	METHOHEXITAL SODIUM	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215488	ONESOURCE SPECIALTY

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