ISOSULFAN BLUE | A090874 | MYLAN INSTITUTIONAL LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| GAND | 2025-10-13 | Terminated 2025-11-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3- Proposed Package Insert Isosulfan Blue Injection re Suitability... FDA-2023-P-4328 Lachman Consulting Services, Inc. submitted a citizen petition requesting FDA approval of a proposed package insert for Isosulfan Blue Injection as part of a suitability petition, likely to establish the drug's suitability for a particular regulatory pathway or to update labeling information for thi | Suitability | 2023-10-05 | Open | Lachman Consulting Services |
Attachment 3 - Draft Package Insert Proposed for Isosulfan Blue Injection, 1%... FDA-2023-P-4297 Lachman Consulting Services, Inc. filed a citizen petition proposing a draft package insert for isosulfan blue injection in a 1 percent, 1 milliliter prefilled syringe formulation as part of a suitability petition to the FDA. | Suitability | 2023-10-03 | Open | Lachman Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.