CYTARABINE | A071471 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Adria Laboratories FDA-1986-P-0246 · 14 docket documents David Bull Laboratories filed this citizen petition requesting that the FDA declare Cytarabine Injection 50mg/mL in a 2mL filled vial suitable for consideration in an abbreviated new drug application under section 505(j)(2)(c) of the Drug Price Competition and Patent Term Restoration Act of 1984. Th | Other | 2024-05-03 | Withdrawn | Adria Laboratories |
Citizen Petition from Quad Pharmaceuticals FDA-1986-P-0293 · 5 docket documents Quad Pharmaceuticals filed this citizen petition under 21 CFR 314.110(f) and sections 505(b) and 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner declare Cytarabine Injection 20 mg/mL in 5 mL and 25 mL vials suitable for consideration in an abbreviated ne | Other | 2024-05-03 | Granted | Quad Pharmaceuticals |
Citizen Petition from Quad Pharmaceuticals FDA-1986-P-0053 · 6 docket documents 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 |
Citizen Petition from Steris Laboratories, Inc. FDA-1992-P-0335 · 6 docket documents David Bull Laboratories Pty. Ltd., filed this citizen petition under sections 505(b) and 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Cytarabine Injection 100mg/mL in 1mL and 5mL vials suitable for abbreviated new drug application consideration as a ready | Other | 2023-07-11 | Granted | Steris Laboratories, Inc. |
Citizen Petition from Steris Laboratories Inc. FDA-1992-P-0122 · 6 docket documents Steris Laboratories Inc., acting as the U.S. Agent for David Bull Laboratories Pty. Ltd., filed this citizen petition requesting that the FDA declare Cytarabine Injection 100 mg/mL in 10 mL and 20 mL pharmacy bulk package vials suitable for consideration as abbreviated new drug applications under Se | Other | 2023-07-11 | Granted | Steris Laboratories Inc. |
Citizen Petition from Abbott Laboratories FDA-1994-P-0257 · 7 docket documents Abbott Laboratories filed this citizen petition under Federal Food, Drug and Cosmetic Act Section 505(j)(2)(c) requesting permission to submit an abbreviated new drug application (ANDA) for Cytarabine Injection, a ready-to-use sterile solution containing 500 mg in a 25 ml vial for intravenous, intra | Other | 2017-07-11 | Withdrawn | Abbott Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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