Orange Book product · Brand (NDA)
NICORETTE
NICOTINE POLACRILEX
At a glance
Sep 25, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2000
26 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
NICOTINE POLACRILEX
Strength
EQ 2MG BASE
Dosage form
GUM, CHEWING
Route
BUCCAL
TE code
Not listed
Application
NDA 018612
Product number
004
Marketing status
OTC
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.
- 2009NICORETTEBrand (NDA)
NDA 022360 · HALEON US HOLDINGS
- 2002NICORETTEBrand (NDA)
NDA 021330 · HALEON US HOLDINGS
- 1996NICORETTEBrand (NDA)
NDA 020066 · HALEON US HOLDINGS
- 2025NICOTINE POLACRILEXGeneric (ANDA)
ANDA 215276 · DR REDDYS LABS SA
- 2022NICOTINE POLACRILEXGeneric (ANDA)
ANDA 214354 · FERTIN PHARMA
- 2022NICOTINE POLACRILEXGeneric (ANDA)
ANDA 215357 · AUROBINDO PHARMA LTD
- 2021NICOTINE POLACRILEXGeneric (ANDA)
ANDA 213266 · AUROBINDO PHARMA
- 2020NICOTINE POLACRILEXGeneric (ANDA)
ANDA 213233 · DR REDDYS LABS SA
- 2020NICOTINE POLACRILEXGeneric (ANDA)
ANDA 212057 · P AND L
- 2020NICOTINE POLACRILEXGeneric (ANDA)
ANDA 212983 · DR REDDYS LABS SA
- 2020NICOTINE POLACRILEXGeneric (ANDA)
ANDA 212796 · DR REDDYS LABS SA
- 2019NICOTINE POLACRILEXGeneric (ANDA)
ANDA 208875 · P AND L
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.
