Orange Book product · Generic (ANDA)
TELMISARTAN AND AMLODIPINE
AMLODIPINE BESYLATE; TELMISARTAN
Generic (ANDA)ANDA 202516RX MYLAN
At a glance
Aug 26, 2014
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2014
12 yr ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Strength
EQ 5MG BASE;40MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 202516
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; TELMISARTAN
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.
