Data updated: Mar 10, 2026
NIACIN
NIACIN
Approved 1972-09-15
22
Indications
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1972-09-15
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
WATSON LABS EVERYLIFE Hikma Sun Pharma AMNEAL PHARMS BEIJING CHARTWELL RX WOCKHARDT Novartis HALSEY MPP PHARMA HIBROW HLTHCARE IMPAX LABS MACLEODS PHARMS LTD ZYDUS PHARMS MK LABS PUREPAC PHARM Teva LANNETT CO INC JUBILANT GENERICS IVAX SUB TEVA PHARMS RISING TABLICAPS Aurobindo Pharma YICHANG HUMANWELL
Active Ingredient: NIACIN
Website: ↗
NIACIN Approval History
Loading approval history...
What NIACIN Treats
22 FDA approvalsOriginally approved for its first indication in 1972 . Covers 22 distinct patient populations.
- Other (22)
Other
(22 approvals)- • Approved indication (Sep 1972)
- • Approved indication (Jan 1973)
- • Approved indication (Aug 1973)
- • Approved indication (Oct 1973)
- • Approved indication (Jan 1974)
- • Approved indication (Apr 1992)
- • Approved indication (Apr 2005)Letter
- • Approved indication (Apr 2005)Letter
- • Approved indication (Mar 2014)
- • Approved indication (Apr 2014)
- • Approved indication (Jul 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Jun 2017)
- • Approved indication (Feb 2018)
- • Approved indication (May 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Jun 2019)
- • Approved indication (Nov 2021)
- • Approved indication (Mar 2022)
- • Approved indication (Aug 2023)
- • Approved indication (Apr 2025) New
- • Approved indication (Jul 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
NIACIN FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.