TRIAMCINOLONE | A083750 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bausch Lomb FDA-2024-P-0109 · 19 docket documents Bausch+Lomb submitted this citizen petition on January 4, 2024, requesting that the FDA refuse to receive or approve any Abbreviated New Drug Application (ANDA) referencing Xipere (triamcinolone acetonide injectable suspension) that uses a different suprachoroidal injector than the FDA-approved SCS | 505(q) | 2024-01-08 | Open | Bausch Lomb |
Citizen Petition from Bausch+Lomb FDA-2023-P-5343 · 19 docket documents Bausch+Lomb filed this citizen petition on November 30, 2023, requesting that the FDA refuse to receive or approve any Abbreviated New Drug Application (ANDA) referencing Xipere (triamcinolone acetonide injectable suspension for suprachoroidal use) unless the submission includes a different injector | 505(q) | 2023-12-05 | Withdrawn | Bausch+Lomb |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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