RAZADYNE

Product NDC

50458-397

11-digit product format

504580397

Labeler code

50458

Product ID

50458-397_ab2b6dfa-8107-11eb-8513-17f1fb2ca371

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

galantamine hydrobromide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA021169

Marketing category

NDA

Marketing start

2001-03-01

Marketing end

2022-03-04

Substance

GALANTAMINE HYDROBROMIDE

Active strength

8 mg/1

Pharmacologic classes

Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record