Viewing data from:

NICARDIPINE HYDROCHLORIDE

NDA

NICARDIPINE HYDROCHLORIDE | N022276 | HIKMA INTERNATIONAL PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain13 active DMFs3 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

LUSOCHIMICA SPANICARDIPINE HYDROCHLORIDE

DMF 94931992

OLON SPANICARDIPINE HYDROCHLORIDE

DMF 101041993

NAVINTA LLCNICARDIPINE HYDROCHLORIDE USP

DMF 197732006

WOCKHARDT LTDNICARDIPINE HYDROCHLORIDE

DMF 212112007

LUSOCHIMICA SPANICARDIPINE HYDROCHLORIDE (INTENDED FOR PARENTERAL USE)

DMF 216252008

HIKMA PHARMACEUTICALSNICARDIPINE HYDROCHLORIDE

DMF 232802009

GLAND PHARMA LTDNICARDIPINE HYDROCHLORIDE USP

DMF 291982015

SICHUAN QINGMU PHARMACEUTICAL CO LTDNICARDIPINE HYDROCHLORIDE

DMF 372872022

MSN LABORATORIES PRIVATE LTDNICARDIPINE HYDROCHLORIDE USP

DMF 375822023

QILU PHARMACEUTICAL CO LTDNICARDIPINE HYDROCHLORIDE USP

DMF 388762023

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNICARDIPINE HYDROCHLORIDE USP

DMF 393262024

MAHI DRUGS PRIVATE LTDNICARDIPINE HYDROCHLORIDE USP

DMF 400132025

METROCHEM API PRIVATE LTDNICARDIPINE HYDROCHLORIDE USP

DMF 402352024

MAPRIMED SAInactiveNICARDIPINE HYDROCHLORIDE

DMF 89191991

MITSUBISHI CORPInactiveNICARDIPINE HYDROCHLORIDE

DMF 107021994

DR REDDYS LABORATORIES LTDInactiveNICARDIPINE HYDROCHLORIDE

DMF 220442008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jul 14, 2025	SUPPL -27	View Letter (PDF)
Nov 4, 2024	SUPPL -25	View Letter (PDF)
Jan 11, 2022	SUPPL -20	View Letter (PDF)
Jun 1, 2021	SUPPL -18	View Letter (PDF)
Sep 26, 2016	SUPPL -11	View Letter (PDF)
Apr 11, 2016	SUPPL -8	View Letter (PDF)
Jan 12, 2009	SUPPL -3	View Letter (PDF)
Jul 31, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG/10ML (2.5MG/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 24, 2008

No patent or exclusivity listings for this strength.

#002 — 20MG/200ML (0.1MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Apr 7, 2016

#003 — 40MG/200ML (0.2MG/ML)

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Apr 7, 2016