Orange Book product · Brand (NDA)
XYLOCAINE PRESERVATIVE FREE
LIDOCAINE HYDROCHLORIDE
At a glance
Jan 19, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 19, 1988
39 yr ago
Today
Pharmaceutical detail
Active ingredient
LIDOCAINE HYDROCHLORIDE
Strength
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 016801
Product number
005
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.
- 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.
