SEMPREX

Product NDC

52244-404

11-digit product format

522440404

Labeler code

52244

Product ID

52244-404_21d2a8a6-108c-4c1d-b1ee-c14f6f2dadc6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

acrivastine and pseudoephedrine hydrochloride

Dosage form

CAPSULE

Route

ORAL

Labeler

Endo Pharmaceuticals Inc.

Application

NDA019806

Marketing category

NDA

Marketing start

2012-01-26

Marketing end

2020-12-31

Substance

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE

Active strength

8 mg/1; mg/1

Pharmacologic classes

Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record