Orange Book product · Generic (ANDA)
LIDOCAINE AND PRILOCAINE
LIDOCAINE; PRILOCAINE
At a glance
Apr 08, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 2022
4 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
LIDOCAINE; PRILOCAINE
Strength
2.5%;2.5%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
ANDA 213923
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LIDOCAINE; PRILOCAINE
- 2003ORAQIXBrand (NDA)
NDA 021451 · DENTSPLY PHARM
- 1998EMLABrand (NDA)
NDA 020962 · ASTRAZENECA
- 1992EMLABrand (NDA)
NDA 019941 · TEVA BRANDED PHARM
- 2024LIDOCAINE AND PRILOCAINEGeneric (ANDA)
ANDA 219120 · ZYDUS LIFESCIENCES
- 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.

