Orange Book product · Brand (NDA)
NORLIQVA
AMLODIPINE BESYLATE
At a glance
Feb 24, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 24, 2022
4 yr 5 mo ago
Today
Patent 11253474 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11253474 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11253474 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11458095 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11458095 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11458095 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11723866 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11723866 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 11723866 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12005141 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12005141 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12005141 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12226528 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12226528 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12226528 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12440441 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12440441 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12440441 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE
Strength
EQ 1MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 214439
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.
- 2025SDAMLOBrand (NDA)
NDA 219531 · BRILLIAN PHARMA
- 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 (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11253474 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 11253474 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3310 |
| 11253474 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 11458095 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 11458095 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3310 |
| 11458095 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 11723866 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 11723866 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 11723866 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3310 |
| 12005141 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 12005141 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 12005141 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3310 |
| 12226528 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 12226528 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3310 |
| 12226528 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 12440441 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 12440441 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 12440441 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3310 |
