TRIAMCINOLONE ACETONIDE | N011600 | EXTROVIS AG
| 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suspension for suprachoroidal use) unless the submission includes a different injector | 505(q) | 2023-12-05 | Withdrawn | Bausch+Lomb |
Citizen Petition from BF Innovation Inc. (on behalf of Bright Future Pharmace... FDA-2018-P-2361 · 6 docket documents BF Innovation Inc., on behalf of Bright Future Pharmaceutical Laboratories Limited, filed this petition requesting that the FDA designate Triamcinolone Acetonide Cream 0.1% (Application No. A085692) by Fougera Pharmaceuticals Inc. as an additional Reference Listed Drug (RLD) to enable approval of ge | 505(q) | 2018-06-19 | Withdrawn | Bright Future Pharmaceutical Laboratories Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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