Basic Information
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
51407-668
Regulatory Information
51407-668
ANDA201087
C73584
September 30, 2022
USA
AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE.These highlights do not include all the information needed to use AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE safely and effectively. See full prescribing information for AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE. AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2009
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
603184490
Active Ingredients
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
CROSPOVIDONE
Code: 2S7830E561
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYVINYL ALCOHOL (100000 MW)
Code: 949E52Z6MY
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
FD&C YELLOW NO. 5
Code: I753WB2F1M
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
Active Moieties
AMLODIPINE
Code: 1J444QC288
HYDROCHLOROTHIAZIDE
Code: 0J48LPH2TH
VALSARTAN
Code: 80M03YXJ7I