Orange Book product · Brand (NDA)
CADUET
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
At a glance
Jul 29, 2004
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 2004
22 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Strength
EQ 2.5MG BASE;EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021540
Product number
009
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 217279 · ALEMBIC
- 2019AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 205199 · APOTEX
- 2019AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 207762 · NEOCUBES PHARMA
- 2014AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 203874 · DR REDDYS
- 2013AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 200465 · MYLAN
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.
