Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207449
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription AP No 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
10/21/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207449Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2018 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/21/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016730 B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016673 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 020179 BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription No AP 207449 FRESENIUS KABI USA
DEXTROSE 5% IN PLASTIC CONTAINER DEXTROSE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 016367 ICU MEDICAL INC

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