Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761082
Company: KASHIV BIOSCIENCES LLC
Company: KASHIV BIOSCIENCES LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RELEUKO | FILGRASTIM-AYOW | 300MCG/ML/VIAL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
RELEUKO | FILGRASTIM-AYOW | 480MCG/1.6ML/VIAL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
RELEUKO | FILGRASTIM-AYOW | 300MCG/0.5ML | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
RELEUKO | FILGRASTIM-AYOW | 480MCG/0.8ML | SOLUTION;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
02/25/2022 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761082Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/01/2023 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761082s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761082Orig1s010ltr.pdf | |
10/28/2022 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761082Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/01/2023 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761082s010lbl.pdf | |
10/28/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf | |
10/28/2022 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf | |
10/28/2022 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s003lbl.pdf | |
02/25/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761082s000lbl.pdf |