Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125294
Company: SICOR BIOTECH
Company: SICOR BIOTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GRANIX | TBO-FILGRASTIM | 300MCG/0.5ML | INJECTABLE; INJECTION | Prescription | None | No | No |
GRANIX | TBO-FILGRASTIM | 480MCG/0.8ML | INJECTABLE; INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/29/2012 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125294Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/21/2023 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125294s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125294Orig1s058ltr.pdf | |
10/09/2019 | SUPPL-48 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125294Orig1s048ltr.pdf |
03/28/2019 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125294s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125294Orig1s046ltr.pdf | |
07/31/2018 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125294Orig1s045ltr.pdf | |
06/21/2017 | SUPPL-42 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s042ltr.pdf | |
02/02/2017 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125294Orig1s040ltr.pdf | |
12/19/2014 | SUPPL-35 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf | |
07/19/2013 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125294Orig1s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/21/2023 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125294s058lbl.pdf | |
03/28/2019 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125294s046lbl.pdf | |
07/31/2018 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125294s045lbl.pdf | |
06/21/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s042lbl.pdf | |
02/02/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf | |
02/02/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125294s040lbl.pdf | |
12/19/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf | |
12/19/2014 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf | |
12/19/2014 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf | |
07/19/2013 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf | |
08/29/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf |