CARBAMAZEPINE | A076729 | TARO PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Quad Pharmaceuticals FDA-1986-P-0053 Quad Pharmaceuticals filed this citizen petition on July 11, 1986, requesting that the FDA Commissioner declare Sterile Cytarabine Injection, USP 1000 mg/vial suitable for consideration as an abbreviated new drug application under Section 505(j) of the Drug Price Competition and Patent Term Restorat | Other | 2024-05-03 | Granted | Quad Pharmaceuticals |
Attachment 2- Reference Listed Drug Labeling Sterile Water for Irrigation USP... FDA-2023-P-4331 Fresenius Kabi USA, LLC filed a petition requesting that the FDA establish Sterile Water for Irrigation USP as a suitable reference listed drug for purposes of demonstrating bioequivalence or establishing the appropriateness of an abbreviated new drug application under the ANDA pathway. | Suitability | 2023-10-03 | Open | Fresenius Kabi USA |
Attachment 1- Orange Book Listing of Sterile Water for Irrigation USP re Suit... FDA-2023-P-4331 Fresenius Kabi USA, LLC filed a petition requesting that the FDA list Sterile Water for Irrigation USP in the Orange Book as a suitable product for pharmaceutical use, addressing regulatory recognition and listing requirements for this sterile solution. | Suitability | 2023-10-03 | Open | Fresenius Kabi USA |
Citizen Petition from Axinn on behalf of Par Sterile Products LLC FDA-2021-P-1211 Attorney Chad Landmon of Axinn law firm filed this citizen petition on behalf of Par Sterile Products LLC pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving Eagle Pharmaceuticals' ANDA No. 211538 for a generic vasopressin product (refe | 505(q) | 2021-11-09 | Denied | Axinn on behalf of Par Sterile Products LLC |
Citizen Petition from Caplin Steriles Limited FDA-2021-P-0163 Caplin Steriles Limited filed this citizen petition on February 5, 2021, requesting that the FDA determine whether Sandostatin (octreotide acetate injection, 0.2 mg and 1 mg strengths) under NDA 019667 held by Novartis Pharmaceuticals was withdrawn from sale for safety or effectiveness reasons. The | 505(q) | 2021-02-05 | Withdrawn | Caplin Steriles Limited |
Citizen Petition from Latham & Watkins LLP on behalf of Par Sterile Products,... FDA-2019-P-6044 Latham & Watkins LLP, on behalf of Par Sterile Products, LLC, filed this petition pursuant to sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA expedite its review of Par's pending Prior Approval Supplements seeking to eliminate the epinephrine overa | 505(q) Stay Request | 2019-12-26 | Denied | Latham & Watkins LLP on behalf of Par Sterile Products |
Attachment 2 Reference Listed Drug Labeling Sterile Water for Irrigation USP ... FDA-2019-P-6047 Fresenius Kabi USA, LLC filed a petition requesting that the FDA designate Sterile Water for Irrigation USP as a suitable reference listed drug for purposes of abbreviated new drug application submissions. | Suitability | 2019-12-26 | Open | Fresenius Kabi USA |
Attachment 3 - "Sterile Bretylium Tosylate 50 mg/mL Injection Package Insert ... FDA-2011-P-0368 I cannot summarize this as a citizen petition because the provided text is only a title reference to a package insert attachment for bretylium tosylate injection, not a complete citizen petition document. To provide an accurate summary identifying the filer, specific action requested, and regulatory | Other | 2011-06-20 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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