Orange Book product · Brand (NDA)
EMLA
LIDOCAINE; PRILOCAINE
At a glance
Dec 30, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 1992
33 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LIDOCAINE; PRILOCAINE
Strength
2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 019941
Product number
001
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.
- 2003ORAQIXBrand (NDA)
NDA 021451 · DENTSPLY PHARM
- 1998EMLABrand (NDA)
NDA 020962 · ASTRAZENECA
- 2024LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 219120 · ZYDUS LIFESCIENCES
- 2022LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 213923 · ALEMBIC
- 2021LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 212482 · PADAGIS US
- 2020LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 213253 · CHARTWELL RX
- 2018LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 205887 · PAI HOLDINGS PHARM
- 2003LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 076290 · HIKMA
- 2003LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 076320 · ENCUBE
- 2003LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 076453 · FOUGERA PHARMS
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.
