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Nifedipine

Generic Name
Nifedipine
Brand Names
Adalat, Afeditab CR, Nifediac, Nifedical, Procardia
Drug Type
Small Molecule
Chemical Formula
C17H18N2O6
CAS Number
21829-25-4
Unique Ingredient Identifier
I9ZF7L6G2L

Overview

Nifedipine, or BAY a 1040, is a first generation dihydropyridine L-type calcium channel blocker, similar to nicardipine. Nifedipine was developed by Bayer and first described in the literature, along with other dihydropyridines, in 1972. Since nifedipine's development, second and third generation dihydropyridines have been developed with slower onsets and longer durations of action. The most popular of the third generation dihydropyridines is amlodipine. Nifedipine was granted FDA approval on 31 December 1981.

Indication

Nifedipine capsules are indicated to treat vasospastic angina and chronic stable angina. Extended release tablets are indicated to treat vasospastic angina, chronic stable angina, and hypertension.

Associated Conditions

  • Achalasia
  • Chronic Stable Angina Pectoris
  • Fissure;Anal
  • Hypertension
  • Hypertensive Emergency
  • Premature Labour
  • Proctalgia
  • Pulmonary Edemas
  • Pulmonary Hypertension (PH)
  • Raynaud's Phenomenon
  • Ureteral Calculus
  • Vasospastic Angina

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/08
Phase 4
Not yet recruiting
2024/02/20
Not Applicable
Not yet recruiting
2024/01/24
Phase 4
Recruiting
2023/07/20
Phase 2
Terminated
2023/07/17
N/A
Recruiting
2023/02/03
Phase 4
Completed
Yang I. Pachankis
2023/01/18
Phase 3
Active, not recruiting
2023/01/17
Not Applicable
Completed
2022/09/22
Phase 3
Recruiting
2022/08/29
Not Applicable
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Lannett Company, Inc.
62175-262
ORAL
90 mg in 1 1
5/30/2023
Aphena Pharma Solutions - Tennessee, LLC
71610-055
ORAL
90 mg in 1 1
5/7/2018
Aphena Pharma Solutions - Tennessee, LLC
67544-185
ORAL
90 mg in 1 1
5/14/2014
NuCare Pharmaceuticals,Inc.
68071-3347
ORAL
60 mg in 1 1
2/12/2021
NuCare Pharmaceuticals,Inc.
68071-2619
ORAL
30 mg in 1 1
1/18/2022
NuCare Pharmaceuticals,Inc.
68071-4334
ORAL
30 mg in 1 1
2/16/2021
Physicians Total Care, Inc.
54868-1521
ORAL
20 mg in 1 1
6/26/2012
Major Pharmaceuticals
0904-7229
ORAL
10 mg in 1 1
8/23/2022
Aphena Pharma Solutions - Tennessee, LLC
43353-929
ORAL
30 mg in 1 1
4/23/2014
Cadila Healthcare Limited
70771-1190
ORAL
30 mg in 1 1
12/17/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
BETA - NICARDIA CAPSULE
SIN12389P
CAPSULE
20 mg
8/14/2003
NIFEDIPINE LA TABLET 60 mg
SIN11680P
TABLET, FILM COATED
60 mg
9/24/2001
AA PHARMA NIFEDIPINE CAPSULE 5 mg
SIN08777P
CAPSULE
5 mg
7/3/1996
CORDIPIN XL TABLET 40 mg
SIN11875P
TABLET, FILM COATED
40 mg
4/12/2002
NIFELAT TABLET 10 mg
SIN07228P
TABLET, FILM COATED
10 mg
10/21/1992
NIFETEX-TR CAPSULE
SIN07439P
CAPSULE
20 mg
5/24/1993
ADALAT LA 30 TABLET 30 mg
SIN07710P
TABLET, FILM COATED
30 mg
5/5/1994
AA PHARMA NIFEDIPINE CAPSULE 10MG
SIN08776P
CAPSULE
10 mg
7/3/1996
DEPIN-E RETARD TABLETS 20 mg
SIN11117P
TABLET
20 mg
9/16/1999
NIFEDIPINE LA TABLET 30 mg
SIN11671P
TABLET, FILM COATED
30 mg
9/21/2001

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Nifedipine Sustained Release Capsules
国药准字H19980107
化学药品
胶囊剂
6/29/2020
Nifedipine Sustained Release Capsules
国药准字H10950309
化学药品
胶囊剂
12/8/2020
Nifedipine Soft Capsules
国药准字H45021523
化学药品
胶囊剂
8/12/2020
Nifedipine Soft Capsules
国药准字H31021764
化学药品
软胶囊剂
7/30/2020
Nifedipine Soft Capsules
国药准字H31020023
化学药品
软胶囊剂
7/30/2020
Nifedipine Soft Capsules
国药准字H19983103
化学药品
软胶囊剂
4/24/2020
Nifedipine Soft Capsules
国药准字H31020241
化学药品
胶囊剂(软胶囊)
5/18/2020
Nifedipine Soft Capsules
国药准字H11020768
化学药品
胶囊剂
7/22/2024
Nifedipine Soft Capsules
国药准字H31021445
化学药品
胶囊剂(软胶囊)
7/14/2020
Nifedipine Soft Capsules
国药准字H42020305
化学药品
软胶囊剂
9/17/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
APO-NIFED CAP 5MG
N/A
N/A
N/A
1/3/1996
NIFELAT RETARD TAB 20MG (SUSTAINED-REL)
N/A
N/A
N/A
7/4/2003

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