NICARDIPINE HYDROCHLORIDE

FDA-2021-P-0308 · 3 docket documents

Exela Pharma Sciences, LLC, through counsel at Hyman, Phelps and McNamara, P.C., filed this citizen petition under Section 505(b) of the FDC Act requesting that FDA assign a Therapeutic Equivalence Evaluation Code to its nicardipine hydrochloride injection NDA 022276, refund PDUFA user fees improper

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-2020-P-0284 · 3 docket documents

Hyman, Phelps & McNamara, P.C. filed this Section 505(j) citizen petition requesting that the FDA amend the Orange Book to designate Nicardipine Hydrochloride Injection, 25 mg/10 mL (2.5mg/mL), Solution approved under NDA 022276 as both a Reference Listed Drug and Reference Standard to enable ANDA a

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