FDA Orange Book · active-ingredient family
Amlodipine besylate; atorvastatin calcium
Amlodipine besylate; atorvastatin calcium is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CADUET · NDA 021540
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CADUETRLD×11 | PHARMACIA | NDA 021540 | AB | Jul 29, 2004 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM×11 | ALEMBIC | ANDA 217279 | AB | May 22, 2025 | |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM×8 | APOTEX | ANDA 205199 | AB | Nov 18, 2019 | |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM×11 | NEOCUBES PHARMA | ANDA 207762 | AB | Jan 11, 2019 | |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM×11 | DR REDDYS | ANDA 203874 | AB | Mar 07, 2014 | |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM×11 | MYLAN | ANDA 200465 | — | Nov 29, 2013 |
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.
Amlodipine besylate; atorvastatin calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
