ERYGEL

Product NDC

40076-415

11-digit product format

400760415

Labeler code

40076

Product ID

40076-415_9cf6aa29-d161-4377-a2e6-f3c7ce24d294

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

erythromycin

Dosage form

GEL

Route

TOPICAL

Labeler

Prestium Pharma, Inc.

Application

NDA050617

Marketing category

NDA

Marketing start

2016-01-27

Marketing end

2020-06-30

Substance

ERYTHROMYCIN

Active strength

20 mg/g

Pharmacologic classes

Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record