CARDENE

FDA-2020-P-2017 · 3 docket documents

Alston & Bird LLP filed this citizen petition on September 28, 2020, requesting that the FDA designate Nicardipine Hydrochloride Premixed Injection 0.1 mg/mL and 0.2 mg/mL in 0.9% Sodium Chloride manufactured by Exela Pharma Sciences under NDA 022276 as alternative Reference Listed Drugs to facilita

FDA-2019-P-1525 · 8 docket documents

Baxter Healthcare Corporation filed this citizen petition under section 505(j) of the FD&C Act requesting that the FDA determine whether CARDENE (Nicardipine Hydrochloride Injection) 25 mg/10mL, approved under NDA 019734 and held by CHIESI USA Inc, was withdrawn for safety and effectiveness reasons,

FDA-2017-P-6479 · 5 docket documents

Teligent Pharma, Inc. filed this petition requesting that the FDA designate an additional Reference Listed Drug for Nicardipine Hydrochloride Injection under Section 505(j) of the FDC Act, because the currently designated RLD, CARDENE Injection (NDA 019734), is not available in the market, thereby p

FDA-2017-P-6291 · 4 docket documents

Lachman Consultant Services, Inc. petitioned the FDA to designate Nicardipine Hydrochloride (25 mg/10 mL) manufactured by Excela Pharma Science (NDA 022276) as an additional reference listed drug for ANDA purposes, arguing that the current RLD by Chiesi USA Inc. (NDA 019734) has not been marketed or

FDA-2017-P-5978 · 6 docket documents

JR Rapoza Associates, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner designate a new reference standard drug for generic drug products containing nicardipine hydrochloride injection 25 mg/10 ml vial (NDA 19734, Cardene) in the Orange Book. The petitioner

FDA-2008-P-0621 · 6 docket documents

EKR Therapeutics, Inc. filed this citizen petition under 21 U.S.C. §§ 351(a), 355(b), 355(j), and 355(q) requesting that FDA refuse to allow Teva Parenteral Medicines, Inc. to relaunch its nicardipine hydrochloride injectable product (NDA 22-276, approved July 24, 2008) until Teva submits intermedia