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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019445
Company: HOSPIRA

Products on NDA 019445

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 25%	DEXTROSE	250MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019445

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/1986	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
07/25/2025	SUPPL-49	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019445s043s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019445Orig1s043s049ltr.pdf
07/25/2025	SUPPL-43	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019445s043s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019445Orig1s043s049ltr.pdf
11/23/1998	SUPPL-6	Efficacy-New Indication		Label is not available on this site.
11/23/1998	SUPPL-4	Efficacy-New Patient Population		Label is not available on this site.

Labels for NDA 019445

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2025	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019445s043s049lbl.pdf
07/25/2025	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019445s043s049lbl.pdf

Therapeutic Equivalents for NDA 019445

DEXTROSE 25%

There are no Therapeutic Equivalents.

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

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