Risedronate Sodium

Product NDC

0378-4714

11-digit product format

003784714

Labeler code

0378

Product ID

0378-4714_062b9bc9-0a74-42b3-9696-fa3012c9d6ac

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

risedronate sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA200477

Marketing category

ANDA

Marketing start

2015-11-30

Marketing end

2019-06-30

Substance

RISEDRONATE SODIUM

Active strength

35 mg/1

Pharmacologic classes

Bisphosphonate [EPC],Diphosphonates [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record