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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202561
Company: AM REGENT

Products on ANDA 202561

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202561

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2013	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202561

CHLOROTHIAZIDE SODIUM

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202561	AM REGENT
CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090896	FRESENIUS KABI USA
CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202462	SAGENT PHARMS INC
CHLOROTHIAZIDE SODIUM	CHLOROTHIAZIDE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091546	SUN PHARM

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