nystatin

Product NDC

0168-0037

11-digit product format

001680037

Labeler code

0168

Product ID

0168-0037_cbc1646c-2fe3-4140-a73c-aaee7c9013c6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

nystatin

Dosage form

SUSPENSION

Route

ORAL

Labeler

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Application

ANDA062517

Marketing category

ANDA

Marketing start

1984-06-07

Marketing end

0000-00-00

Substance

NYSTATIN

Active strength

100000 [USP'U]/mL

Pharmacologic classes

Polyene Antifungal [EPC],Polyenes [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record