Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203129
Company: FRESENIUS KABI USA

Products on ANDA 203129

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203129

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2015	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
01/21/2022	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/28/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
08/09/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203129

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION; EQ 4MG 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 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	208689	AMNEAL
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206781	EUGIA PHARMA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	084916	FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203129	FRESENIUS KABI USA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	215654	GLAND PHARMA LTD
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211451	HIKMA
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040803	MYLAN LABS LTD
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	207521	SOMERSET
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	084282	WEST-WARD PHARMS INT