Orange Book product · Brand (NDA)
XYLOCAINE W/ EPINEPHRINE
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
At a glance
Nov 13, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 13, 1986
40 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Strength
0.005MG/ML;1%
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 006488
Product number
018
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.
