Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019445
Company: HOSPIRA
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
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
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.

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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