FDA Labeling for NDA 022276 SUPPL-25 Nicardipine Hydrochloride Injection – August 16, 2024

FDA Labeling for NDA 022276 SUPPL-25 Nicardipine Hydrochloride Injection – August 16, 2024

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Original Request: Requesting the latest approved Aug 16, 2024 labeling from NDA 022276 SUPPL-25, NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE held by Hikma Pharmaceuticals, as listed on Drugs@FDA website. Please provide the labeling for both strengths [40MG/200ML (0.2MG/ML) and 20MG/200ML (0.1MG/ML)] for primary container (flexible plastic container/bag), secondary container (Overwrap), Carton, and the package insert.
Tags: Pharma, NDA, 2024
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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