Orange Book product · Brand (NDA)
NIASPAN
NIACIN
At a glance
Jul 28, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 1997
29 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
NIACIN
Strength
1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020381
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —WAMPOCAPBrand (NDA)
NDA 011073 · MEDPOINTE PHARM HLC
- 2025NIACINGeneric (ANDA)
ANDA 207726 · MPP PHARMA
- 2025NIACINGeneric (ANDA)
ANDA 203285 · ZYDUS PHARMS
- 2023NIACINGeneric (ANDA)
ANDA 213090 · HIBROW HLTHCARE
- 2022NIACINGeneric (ANDA)
ANDA 204934 · MACLEODS PHARMS LTD
- 2021NIACINGeneric (ANDA)
ANDA 214428 · BEIJING
- 2019NIACINGeneric (ANDA)
ANDA 212017 · YICHANG HUMANWELL
- 2019NIACINGeneric (ANDA)
ANDA 203742 · RISING
- 2018NIACINGeneric (ANDA)
ANDA 209156 · JUBILANT GENERICS
- 2018NIACINGeneric (ANDA)
ANDA 209236 · AUROBINDO PHARMA LTD
- 2017NIACINGeneric (ANDA)
ANDA 203899 · LANNETT CO INC
- 2015NIACINGeneric (ANDA)
ANDA 204178 · AMNEAL PHARMS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
