Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103362
Company: BERLEX LABS
Company: BERLEX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEUKINE | SARGRAMOSTIM | 250UG/ML | VIAL | Prescription | None | No | No |
LEUKINE | SARGRAMOSTIM | 500UG/ML | VIAL | 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 |
---|---|---|---|---|---|---|---|
03/05/1991 | ORIG-1 | Approval | N/A; Orphan |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/05/2022 | SUPPL-5249 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103362s5249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103362Orig1s5249ltr.pdf | |
03/29/2018 | SUPPL-5240 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103362Orig1s5240ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/103362Orig1s5240.pdf | |
02/10/2017 | SUPPL-5237 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103362Orig1s5237ltr.pdf | |
11/04/2008 | SUPPL-5140 | Supplement |
Label is not available on this site. |
||
03/14/2002 | SUPPL-5012 | Supplement |
Label is not available on this site. |
||
11/24/1995 | SUPPL-1048 | Supplement |
Label is not available on this site. |
||
12/22/1995 | SUPPL-1045 | Supplement |
Label is not available on this site. |
||
09/15/1995 | SUPPL-1033 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/05/2022 | SUPPL-5249 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103362s5249lbl.pdf | |
03/29/2018 | SUPPL-5240 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103362s5240lbl.pdf | |
02/10/2017 | SUPPL-5237 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103362s5237lbl.pdf |