Orange Book product · Brand (NDA)
XYLOCAINE W/ EPINEPHRINE
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Strength
0.01MG/ML;1%
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 006488
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2004LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEBrand (NDA)
NDA 021486 · EMPI
- 2004LIDOSITE TOPICAL SYSTEM KITBrand (NDA)
NDA 021504 · VYTERIS
- 1995IONTOCAINEBrand (NDA)
NDA 020530 · IOMED
- —XYLOCAINE DENTAL WITH EPINEPHRINEBrand (NDA)
NDA 021381 · DENTSPLY PHARM
- —XYLOCAINE W/ EPINEPHRINEBrand (NDA)
NDA 010418 · ASTRAZENECA
- 2021LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 208475 · B BRAUN MEDICAL
- 2008LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 078772 · HOSPIRA
- 1993LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 040057 · EASTMAN KODAK
- 1988LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 089635 · HOSPIRA
- 1988LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 089649 · HOSPIRA
- 1988LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 089645 · HOSPIRA
- 1988LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEGeneric (ANDA)
ANDA 089650 · HOSPIRA
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.
