Diclofenac Sodium and Misoprostol Delayed-Release

Product NDC

63126-341

11-digit product format

631260341

Labeler code

63126

Product ID

63126-341_8292f0dd-d941-43ec-aae0-6f29ef1c84e5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Diclofenac Sodium and Misoprostol

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Labeler

Yung Shin Pharmaceutical Industrual Co., Ltd.

Application

ANDA205143

Marketing category

ANDA

Marketing start

2020-06-30

Marketing end

0000-00-00

Substance

DICLOFENAC SODIUM; MISOPROSTOL

Active strength

50 mg/1; ug/1

Pharmacologic classes

Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record