Orange Book product · Generic (ANDA)
NICOTINE POLACRILEX
NICOTINE POLACRILEX
At a glance
May 13, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 13, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
NICOTINE POLACRILEX
Strength
EQ 2MG BASE
Dosage form
TROCHE/LOZENGE
Route
ORAL
TE code
Not listed
Application
ANDA 215357
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NICOTINE POLACRILEX
- 2009NICORETTEBrand (NDA)
NDA 022360 · HALEON US HOLDINGS
- 2002NICORETTEBrand (NDA)
NDA 021330 · HALEON US HOLDINGS
- 1996NICORETTEBrand (NDA)
NDA 018612 · 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
- 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.
