Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761201
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEMGLEE | INSULIN GLARGINE-YFGN | 10ML(100UNITS/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
SEMGLEE | INSULIN GLARGINE-YFGN | 3ML(100UNITS/ML) | 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 |
---|---|---|---|---|---|---|---|
07/28/2021 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761201Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761201Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761201Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/29/2023 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761201Orig1s008ltr.pdf | |
05/30/2023 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761201Orig1s007ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/29/2023 | SUPPL-8 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s008lbl.pdf | |
05/30/2023 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf | |
05/30/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf | |
05/30/2023 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761201s007lbl.pdf | |
07/28/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761201Orig1s000lbl.pdf |