Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203451
Company: INTL MEDICATION SYS

Products on ANDA 203451

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203451

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/26/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 203451

DEXTROSE 50%

INJECTABLE;INJECTION; 500MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019445	HOSPIRA
DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	203451	INTL MEDICATION SYS