FDA — authorised 24 July 1957
- Application: NDA011073
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: WAMPOCAP
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Niaspan in United States
FDA authorised Niaspan on 24 July 1957
Marketing authorisations
FDA — authorised 1 August 1973
- Application: ANDA083525
- Marketing authorisation holder: MK LABS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 1982
- Application: ANDA085172
- Marketing authorisation holder: WATSON LABS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 1992
- Application: ANDA081134
- Marketing authorisation holder: WOCKHARDT
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 1997
- Application: NDA020381
- Marketing authorisation holder: ABBVIE
- Local brand name: NIASPAN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2005
- Application: ANDA076250
- Marketing authorisation holder: BARR
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA090446
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA090860
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA090892
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 July 2015
- Application: ANDA203578
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA203742
- Marketing authorisation holder: RISING
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 June 2019
- Application: ANDA212017
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 November 2021
- Application: ANDA214428
- Marketing authorisation holder: BEIJING
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 August 2023
- Application: ANDA213090
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 April 2025
- Application: ANDA203285
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA083453
- Marketing authorisation holder: HALSEY
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084237
- Marketing authorisation holder: TABLICAPS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Niaspan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Niaspan approved in United States?
Yes. FDA authorised it on 24 July 1957; FDA authorised it on 1 August 1973; FDA authorised it on 18 February 1982.
Who is the marketing authorisation holder for Niaspan in United States?
MEDPOINTE PHARM HLC holds the US marketing authorisation.