Ganciclovir

Product NDC

24201-500

11-digit product format

242010500

Labeler code

24201

Product ID

24201-500_8c6aaaac-7654-1ad8-e053-2995a90af844

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ganciclovir

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Leucadia Pharmaceuticals

Application

ANDA212001

Marketing category

ANDA

Marketing start

2019-11-20

Marketing end

0000-00-00

Substance

GANCICLOVIR SODIUM

Active strength

500 mg/10mL

Pharmacologic classes

Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record