Orange Book product · Generic (ANDA)
NIACIN
NIACIN
At a glance
Jul 25, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
NIACIN
Strength
1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 207726
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NIACIN
- 1997NIASPANBrand (NDA)
NDA 020381 · ABBVIE
- —WAMPOCAPBrand (NDA)
NDA 011073 · MEDPOINTE PHARM HLC
- 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.
