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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/10/03 | N/A | UNKNOWN | |||
2018/07/23 | Phase 4 | Terminated | |||
2018/05/31 | Phase 3 | Completed | |||
2018/04/27 | N/A | Recruiting | |||
2018/04/24 | Phase 4 | Completed | |||
2017/10/30 | Phase 2 | UNKNOWN | Services Institute of Medical Sciences, Pakistan | ||
2017/08/10 | Early Phase 1 | Withdrawn | |||
2017/08/10 | Phase 1 | UNKNOWN | |||
2017/06/21 | N/A | Completed | |||
2017/05/02 | Phase 1 | Completed |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Nifedipine | ORAL | 30 mg in 1 1 | 2019/03/08 | 71335-1550 | |
Nifedipine | ORAL | 30 mg in 1 1 | 2023/02/07 | 68084-597 | |
Nifedipine | ORAL | 90 mg in 1 1 | 2023/02/07 | 68084-603 | |
Nifedipine | ORAL | 30 mg in 1 1 | 2019/03/08 | 50742-260 | |
NIFEDIPINE | ORAL | 90 mg in 1 1 | 2024/01/17 | 70771-1367 | |
Nifedipine | ORAL | 90 mg in 1 1 | 2019/03/08 | 50742-262 | |
Nifedipine | A-S Medication Solutions | ORAL | 30 mg in 1 1 | 2019/03/08 | 50090-6203 |
Nifedipine | ORAL | 60 mg in 1 1 | 2017/02/10 | 50742-621 | |
Nifedipine | ORAL | 90 mg in 1 1 | 2021/06/07 | 59651-297 | |
Nifedipine | ORAL | 90 mg in 1 1 | 2014/01/18 | 33261-840 |
EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
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Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|
No Singapore products found
No Singapore products found for this drug
China Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
Nifedipine Sustained-release Tablets | 国药准字H11022296 | 片剂 | N/A | 10mg | Chemical Drug | Approved | 2020/04/30 | Domestic | |
Nifedipine Sustaimnd Release Tablets | 国药准字H61023583 | 片剂(缓释片) | N/A | 10mg | Chemical Drug | Approved | 2020/07/31 | Domestic | |
Nifedipine Sustained-release Tablets(I) | 国药准字H20113545 | 片剂 | N/A | 10mg | Chemical Drug | Approved | 2021/12/10 | Domestic | |
Nifedipine Tablets | 国药准字H23022425 | 片剂 | N/A | 10mg(糖衣片) | Chemical Drug | Approved | 2015/04/18 | Domestic | |
Nifedipine Tablets | 国药准字H46020741 | 片剂 | N/A | 10mg | Chemical Drug | Approved | 2015/04/28 | Domestic | |
Nifedipine Tablets | 国药准字H37020535 | 片剂 | N/A | 10mg | Chemical Drug | Approved | 2015/04/24 | Domestic | |
Nifedipine Tablets | 国药准字H20045708 | 片剂 | N/A | 5mg | Chemical Drug | Approved | 2021/02/23 | Domestic | |
Nifedipine Tablets | 国药准字H37023033 | 片剂 | N/A | 5mg | Chemical Drug | Approved | 2021/03/31 | Domestic | |
Nifedine Tablets | 国药准字H20055644 | 片剂 | N/A | 10mg | Chemical Drug | Approved | 2016/01/27 | Domestic | |
Nifedipine Tablets | 国药准字H22023176 | 片剂 | N/A | 10mg | Chemical Drug | Approved | 2020/05/22 | Domestic |
Australia Approved Products
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Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|
No Australia products found
No Australia products found for this drug