Orange Book product · Brand (NDA)
SDAMLO
AMLODIPINE BESYLATE
At a glance
Jul 24, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE
Strength
EQ 10MG BASE/BOT
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 219531
Product number
003
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.
- 2022NORLIQVABrand (NDA)
NDA 214439 · CMP DEV LLC
- 2007AMLODIPINE BESYLATEBrand (NDA)
NDA 022026 · SYNTHON PHARMS
- 1992NORVASCBrand (NDA)
NDA 019787 · VIATRIS
- 2026AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 201380 · GRAVITI PHARMS
- 2026AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 219686 · TEVA PHARMS INC
- 2018AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 206524 · SUNSHINE
- 2016AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 207821 · PURACAP LABS BLU
- 2016AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 090752 · CHINA RESOURCES
- 2015AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 206367 · INVAGEN PHARMS
- 2015AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 204900 · SOVEREIGN PHARMS
- 2013AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 203245 · UNICHEM
- 2013AMLODIPINE BESYLATEGeneric (ANDA)
ANDA 202553 · ACCORD HLTHCARE
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.
