Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210762
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/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
05/03/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210762Orig1s000ltr.pdf

FENTANYL CITRATE PRESERVATIVE FREE

INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 019115 HOSPIRA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 210762 FRESENIUS KABI USA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription No AP 072786 HOSPIRA
FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 019101 WEST-WARD PHARMS INT
SUBLIMAZE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 016619 AKORN

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