ZONISAMIDE | N020789 | ADVANZ PHARMA (US) CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4286 · 7 docket documents Newcastle Bioscience LLC filed this citizen petition on October 1, 2023 requesting that the FDA declare Zonisamide Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an abbreviated new drug application (ANDA), based on the reference listed drug Zonegr | Suitability | 2023-10-03 | Denied | Newcastle Bioscience LLC |
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2019-P-0076 · 8 docket documents Unichem Pharmaceuticals (USA) Inc. filed this citizen petition on December 28, 2018, requesting that the FDA determine whether the 50 mg strength of Sunovion Pharmaceuticals' ZONEGRAN (zonisamide) Capsules, approved under NDA N020789, was discontinued for safety or effectiveness reasons, and if not, | 505(q) | 2019-01-07 | Granted | Unichem Pharmaceuticals (USA), Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0131 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Zonisamide Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an ANDA, representing a change in dosage form from | Other | 2018-01-11 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0130 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Zonisamide Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an abbreviated new drug application, representing a change in dosage form from ca | Other | 2018-01-09 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0098 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zonisamide Capsules USP in 150 mg, 200 mg, and 300 mg strengths suitable for submission as an ANDA, with Zonegran | Other | 2018-01-09 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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