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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040803
Company: MYLAN LABS LTD

Products on ANDA 040803

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 040803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2008	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
06/05/2024	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
07/03/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040803

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	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
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE;INJECTION	Prescription	No	AP	084282	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

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