Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210966
Company: EUGIA PHARMA

Products on ANDA 210966

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210966

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2020	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
06/05/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210966

DEXAMETHASONE SODIUM PHOSPHATE

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
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	087702	HIKMA
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 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