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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218261
Company: LEADING

Products on ANDA 218261

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXAZEPAM	OXAZEPAM	10MG	CAPSULE;ORAL	Prescription	AB	No	No
OXAZEPAM	OXAZEPAM	15MG	CAPSULE;ORAL	Prescription	AB	No	No
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218261

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218261

OXAZEPAM

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXAZEPAM	OXAZEPAM	10MG	CAPSULE;ORAL	Prescription	No	AB	072253	ACTAVIS ELIZABETH
OXAZEPAM	OXAZEPAM	10MG	CAPSULE;ORAL	Prescription	No	AB	071756	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	10MG	CAPSULE;ORAL	Prescription	No	AB	218261	LEADING
OXAZEPAM	OXAZEPAM	10MG	CAPSULE;ORAL	Prescription	No	AB	071026	TP ANDA HOLDINGS

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXAZEPAM	OXAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	072253	ACTAVIS ELIZABETH
OXAZEPAM	OXAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	071756	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	218261	LEADING
OXAZEPAM	OXAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	071026	TP ANDA HOLDINGS

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	072253	ACTAVIS ELIZABETH
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071756	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	218261	LEADING
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071026	TP ANDA HOLDINGS

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