ROWEEPRA XR

Product NDC

69102-200

11-digit product format

691020200

Labeler code

69102

Product ID

69102-200_601eaa2b-5c17-74c6-e053-2991aa0a1123

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

levetiracetam

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

OWP Pharmaceuticals, Inc.

Application

ANDA202095

Marketing category

ANDA

Marketing start

2017-12-22

Marketing end

0000-00-00

Substance

LEVETIRACETAM

Active strength

500 mg/1

Pharmacologic classes

Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record