Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761275
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TYENNE | TOCILIZUMAB-AAZG | 162MG/0.9ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
TYENNE | TOCILIZUMAB-AAZG | 80MG/4ML | INJECTABLE;INTRAVENOUS | Prescription | None | No | No |
TYENNE | TOCILIZUMAB-AAZG | 200MG/10ML | INJECTABLE;INTRAVENOUS | Prescription | None | No | No |
TYENNE | TOCILIZUMAB-AAZG | 400MG/20ML | INJECTABLE;INTRAVENOUS | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
03/05/2024 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761275Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/13/2024 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s013ltr.pdf | |
12/03/2024 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s011ltr.pdf | |
09/05/2024 | SUPPL-1 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/13/2024 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf | |
12/13/2024 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s013lbl.pdf | |
12/03/2024 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf | |
12/03/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275s011lbl.pdf | |
09/05/2024 | SUPPL-1 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s001lbl.pdf | |
03/05/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s000Correctedlbl.pdf |