DEPOCYT

FDA-1986-P-0246

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

FDA-1986-P-0246

Adria Laboratories (doing business as David Bull Laboratories) filed this citizen petition requesting that the FDA declare Cytarabine Injection 50mg/mL in a 20mL vial as a Pharmacy Bulk Package suitable for consideration in an abbreviated new drug application under 21 CFR 314.110(f) and Section 505(

FDA-1986-P-0246

Adria Laboratories filed this citizen petition on May 26, 1989, requesting that the FDA determine that Tarabine PFS (Cytarabine Injection) 2g/100mL at 20 mg/mL in a Pharmacy Bulk Package vial is suitable for consideration in an abbreviated new drug application under 21 CFR 314.110 and section 505(j)

FDA-1986-P-0246

FDA-1986-P-0246

David Bull Laboratories Pty. Ltd. filed this citizen petition under 21 CFR 314.110(f) and Section 505(j)(2)(c) of the Drug Price Competition and Patent Term Restoration Act of 1984, requesting that the FDA declare Cytarabine Injection 50mg/mL in a 10mL filled vial suitable for consideration in an ab

FDA-1986-P-0293

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

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

FDA-1992-P-0335

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

FDA-1992-P-0122

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

FDA-1994-P-0257

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