Data updated: May 26, 2026
ADALAT CC (nifedipine)
Cardiovascular
Approved 1993-04-21
1
Indication
--
Phase 3 Trials
33
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1993-04-21
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
ADALAT CC Approval History
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
51 FDA actions from 1993 to 2016
May 2016 SUPPL
Mfg · Manufacturing (CMC)
Mar 2015 SUPPL
Mfg · Manufacturing (CMC)
Apr 1999 SUPPL
Mfg
Dec 1998 SUPPL
Mfg
Jul 1996 SUPPL
Mfg
Mar 1996 SUPPL
Mfg
Mar 1996 SUPPL
Mfg
Jan 1996 SUPPL
Mfg
Jun 1995 SUPPL
Mfg
Jul 1994 SUPPL
Mfg
Jul 1994 SUPPL
Label
Dec 1993 SUPPL
Mfg
Jul 1993 SUPPL
Label
Apr 1993 ORIGINAL
Update
What ADALAT CC Treats
1 FDA approvalsOriginally approved for its first indication in 1993 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 1993)
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Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05139238 results posted | AAAT5925 | Ph 4 | terminated | Postpartum Hypertension Study |
| NCT03976063 TOCOPROM | P160917 | Ph 3 | active not recruiting | Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation |
| NCT06915792 PEACE | IRB-24-6051 | Ph 4 | not yet recruiting | PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy |
| NCT05955040 | 1889318 | Ph 2 | terminated | Treatment of Elevated Blood Pressures in Early Pregnancy |
| NCT03949478 | TPS-1.0 | Ph 2 | recruiting | Treating Postictal Symptoms Using Ibuprofen and Nifedipine |
| NCT02438371 results posted | HSC-MS-15-0134 | Ph 4 | terminated | Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor |
| NCT03542552 | ONIMS | Ph 3 | completed | Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa |
| NCT03506724 results posted | GCO 17-0257 Maimonides IRB 2018-02-17 | Ph 4 | completed | Response to Anti-hypertensives in Pregnant and Postpartum Patients |
| NCT02132533 Nifedipine results posted | 122013-063 | Ph 3 | completed | Nifedipine for Acute Tocolysis of Preterm Labor |
| NCT01912677 | 4000 | Ph 4 | completed | Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy |
| NCT02527109 | RDD 110 | Ph 2, Ph 3 | completed | The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure |
| NCT03005496 | 50/UN.2F1/ETIK/2016 | Ph 4 | completed | The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β |
| NCT02591004 | A21102015 | Ph 2, Ph 3 | completed | Calcium Channel Blockers Compared to Magnesium Sulfate in Fetal Cerebral Blood Flow |
| NCT00712738 | 080157 08-DK-0157 | Ph 1 | completed | Oral Nifedipine to Treat Iron Overload |
| NCT02583633 | ShirazSUMS | Ph 4 | completed | Transdermal Nitroglycerin and Nifedipine in Preterm Labor |
| NCT01314859 | MMC-NIF-2010-01 2010-024122-37 | Ph 3 | withdrawn | Nifedipine Treatment in Preterm Labor |
| NCT00620724 | 2005/065/HP | Ph 2 | completed | Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa |
| NCT01830530 HIGHCARE-A | 09F102 | Ph 4 | completed | HIGH Altitude CArdiovascular REsearch in the ANDES |
| NCT01167153 EXAM results posted | CVAA489ACN02 | Ph 4 | completed | Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients |
| NCT00599898 | EMC070048CTIL same as unique protocol ID | Ph 4 | completed | Nifedipine Compared to Atosiban for Treating Preterm Labor |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADALAT CC FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.