Drugs@FDA: FDA Approved Drug Products

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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 None Yes No
DEXTROSE 50% IN PLASTIC CONTAINER DEXTROSE 500MG/ML INJECTABLE;INJECTION Prescription None 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
02/01/2017 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

09/03/2014 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/23/1998 SUPPL-6 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19445s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19445-s4-s6.cfm
11/23/1998 SUPPL-4 Efficacy-New Patient Population Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19445s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19445-s4-s6.cfm
09/23/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/27/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1987 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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