Amlodipine and Olmesartan Medoxomil

Product NDC

0093-7028

11-digit product format

000937028

Labeler code

0093

Product ID

0093-7028_1fcd1eb5-ae5d-4289-a542-810d9a7570e4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amlodipine and Olmesartan Medoxomil

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Teva Pharmaceuticals USA, Inc.

Application

ANDA091154

Marketing category

ANDA

Marketing start

2016-10-26

Marketing end

2020-07-31

Substance

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Active strength

5 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

0000-00-00

Current FDA listing

Historical FDA.report record