Amlodipine and Olmesartan Medoxomil

Product NDC

60505-4584

11-digit product format

605054584

Labeler code

60505

Product ID

60505-4584_575d2388-51c2-1057-b412-43d387051b92

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amlodipine and Olmesartan Medoxomil

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Apotex Corp.

Application

ANDA207807

Marketing category

ANDA

Marketing start

2017-08-15

Marketing end

0000-00-00

Substance

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

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

2021-12-31

Current FDA listing

Historical FDA.report record