Healthy Accents Cetirizine-D

Product NDC

55316-176

11-digit product format

553160176

Labeler code

55316

Product ID

55316-176_a0745032-a116-4fa7-8201-fd2e9dd813a1

Type

HUMAN OTC DRUG

Nonproprietary name

Cetirizine HCl, Pseudoephedrine HCl

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

DZA Brands LLC

Application

ANDA077170

Marketing category

ANDA

Marketing start

2011-07-13

Marketing end

2019-11-01

Substance

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

5 mg/1; mg/1

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record