Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210762
Company: FRESENIUS KABI USA
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/07/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 | 212086 | FRESENIUS KABI USA |
FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019101 | HIKMA |
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 |
SUBLIMAZE PRESERVATIVE FREE | FENTANYL CITRATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016619 | RISING |