Orange Book product · Generic (ANDA)
AMLODIPINE BESYLATE
AMLODIPINE BESYLATE
At a glance
Jan 22, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 22, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE
Strength
EQ 2.5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 219686
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMLODIPINE BESYLATE
- 2025SDAMLOBrand (NDA)
NDA 219531 · BRILLIAN PHARMA
- 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
- 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.
