Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090896
Company: FRESENIUS KABI USA

Products on ANDA 090896

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 090896

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2009	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090896s000ltr.pdf

Therapeutic Equivalents for ANDA 090896

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