DEPOCYT

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

I am unable to provide the requested summary because the provided text is largely illegible and contains primarily stamps, routing marks, and fragmented characters rather than coherent petition content. The only clearly readable information is that Adria Laboratories filed this petition to the FDA's

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

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-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