Orange Book product · Generic (ANDA)
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE
At a glance
Jul 29, 2025
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
LIDOCAINE HYDROCHLORIDE
Strength
2%
Dosage form
SOLUTION
Route
ORAL
TE code
AT
Application
ANDA 219759
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LIDOCAINE HYDROCHLORIDE
- 2008AKTENBrand (NDA)
NDA 022221 · THEA PHARMA
- —LIDOCAINE HYDROCHLORIDEBrand (NDA)
NDA 017508 · ABRAXIS PHARM
- —LIDOCAINE HYDROCHLORIDEBrand (NDA)
NDA 017701 · INTL MEDICATION
- —LIDOCAINE HYDROCHLORIDEBrand (NDA)
NDA 018543 · INTL MEDICATION
- 2026LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220071 · VIWIT PHARM
- 2025LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219535 · ANTHEA PHARMA
- 2023LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217693 · MANKIND PHARMA
- 2023LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217692 · MANKIND PHARMA
- 2022LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215132 · AFAXYS
- 2021LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214336 · ASPIRO
- 2021LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214339 · ASPIRO
- 2020LIDOCAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212821 · HUONS
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.
