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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GenRx Nifedipine 20mg tablet blister pack | 127284 | Medicine | A | 7/24/2006 | |
| CHEMMART Nifedipine 20mg tablet blister pack | 127283 | Medicine | A | 7/24/2006 | |
| APO-NIFEDIPINE XR nifedipine 30mg controlled release tablet blister pack | 152207 | Medicine | A | 10/21/2008 | |
| APO-NIFEDIPINE XR nifedipine 60mg controlled release tablet blister pack | 152208 | Medicine | A | 10/21/2008 | |
| ROHALO NADIPINIA nifedipine 5 mg capsule | 46350 | Rohalo Pharmaceutical Pty Ltd | Medicine | A | 8/25/1993 |
Help Us Improve
Your feedback helps us provide better drug information and insights.