Amlodipine, Valsartan and Hydrochlorothiazide

Product NDC

13668-326

11-digit product format

136680326

Labeler code

13668

Product ID

13668-326_95a9b357-3047-0ed6-e053-2995a90aff61

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amlodipine, Valsartan and Hydrochlorothiazide

Dosage form

TABLET

Route

ORAL

Labeler

Torrent Pharmaceuticals Limited

Application

ANDA201593

Marketing category

ANDA

Marketing start

2015-06-03

Marketing end

2020-03-31

Substance

AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE

Active strength

5 mg/1; mg/1; mg/1

Pharmacologic classes

Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record