Terazol 7

Product NDC

50458-535

11-digit product format

504580535

Labeler code

50458

Product ID

50458-535_9a055cd8-638b-11ea-a644-412efc2ca371

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

TERCONAZOLE

Dosage form

CREAM

Route

VAGINAL

Labeler

Janssen Pharmaceuticals, Inc.

Application

NDA019579

Marketing category

NDA

Marketing start

1987-12-31

Marketing end

2020-06-15

Substance

TERCONAZOLE

Active strength

4 mg/g

Pharmacologic classes

Azole Antifungal [EPC],Azoles [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record