EMADINE

Product NDC

0065-0325

11-digit product format

000650325

Labeler code

0065

Product ID

0065-0325_c9eaf688-c6b4-496b-9cf8-ad55d7bcd7ee

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

EMEDASTINE DIFUMARATE

Dosage form

SOLUTION/ DROPS

Route

OPHTHALMIC

Labeler

Alcon Laboratories, Inc.

Application

NDA020706

Marketing category

NDA

Marketing start

1998-02-15

Marketing end

0000-00-00

Substance

EMEDASTINE DIFUMARATE

Active strength

1 mg/mL

Pharmacologic classes

Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record