Application 761412
- Type
- BLA
- Sponsor
- SUNSHINE LAKE PHARMA CO LTD
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761412 | Langlara | insulin glargine-aldy | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LANGLARA | INSULIN GLARGINE-ALDY | INJECTABLE;SUBCUTANEOUS | 100UNITS/ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85799 | ORIG | 2026-05-01 |
| 85798 | ORIG | 2026-05-01 |