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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040491
Company: FRESENIUS KABI USA

Products on ANDA 040491

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040491

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2003	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/03/2014	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040491s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040491Orig1s008,040572Orig1s002,084916Orig1s066ltr.pdf
06/09/2005	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 040491

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040491s008lbl.pdf

Therapeutic Equivalents for ANDA 040491

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 10MG PHOSPHATE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	210966	EUGIA PHARMA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	210967	EUGIA PHARMA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040572	FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	209192	FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215654	GLAND PHARMA LTD
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217797	MICRO LABS
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040802	MYLAN LABS LTD
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211036	SOMERSET THERAPS LLC
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	087702	WEST-WARD PHARMS INT
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	208690	AMNEAL
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040491	FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	207442	SOMERSET THERAPS LLC

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