Theophylline

Product NDC

0378-0487

11-digit product format

003780487

Labeler code

0378

Product ID

0378-0487_c643fde6-233c-4d44-b3dc-51243f1d0337

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Theophylline

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA040560

Marketing category

ANDA

Marketing start

2017-03-07

Marketing end

2020-10-31

Substance

THEOPHYLLINE ANHYDROUS

Active strength

600 mg/1

Pharmacologic classes

Methylxanthine [EPC],Xanthines [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record