Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761212
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARMLUPEG | PEGFILGRASTIM-UNNE | 6MG/0.6ML | INJECTION;SOLUTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/28/2025 | ORIG-1 | Approval | N/A |
Letter (PDF)
Review Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761212Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761212Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761212Orig1s000TOC.html |