Orange Book product · Brand (NDA)
ORAQIX
LIDOCAINE; PRILOCAINE
At a glance
Dec 19, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2003
22 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LIDOCAINE; PRILOCAINE
Strength
2.5%;2.5%
Dosage form
GEL
Route
PERIODONTAL
TE code
Not listed
Application
NDA 021451
Product number
001
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.
- 1998EMLABrand (NDA)
NDA 020962 · ASTRAZENECA
- 1992EMLABrand (NDA)
NDA 019941 · TEVA BRANDED PHARM
- 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.
