Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206404
Company: SAGENT PHARMS INC

Products on ANDA 206404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2016	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
08/15/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/27/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206404

PENTOBARBITAL SODIUM

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEMBUTAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	083246	RISING
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206677	BPI LABS
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203619	HIKMA
PENTOBARBITAL SODIUM	PENTOBARBITAL SODIUM	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206404	SAGENT PHARMS INC