Amlodipine and Valsartan

Product NDC

42291-023

11-digit product format

422910023

Labeler code

42291

Product ID

42291-023_75c86c8a-5a23-19d0-e053-2991aa0aa7d4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amlodipine and valsartan

Dosage form

TABLET

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA090011

Marketing category

ANDA

Marketing start

2018-09-11

Marketing end

0000-00-00

Substance

AMLODIPINE; VALSARTAN

Active strength

10 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]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record