Orange Book product · Generic (ANDA)
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
At a glance
Jan 11, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 11, 2019
7 yr 7 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
ANDA 207762
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; ATORVASTATIN CALCIUM
- 2004CADUETBrand (NDA)
NDA 021540 · PHARMACIA
- 2025AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 217279 · ALEMBIC
- 2019AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMGeneric (ANDA)
ANDA 205199 · APOTEX
- 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.
