UNI-DUR Detail

Drug Name(s):
UNI-DUR

FDA Application No.:
NDA 089823

Active Ingredient(s):
THEOPHYLLINE

Company:
SCHERING

Original Approval or Tentative Approval Date:
January 30, 1995

Products on Application NDA 089823:

Active Ingredients	Strenght	Dosage Form	Marketing Status	TE Code
THEOPHYLLINE	600MG	TABLET, EXTENDED RELEASE; ORAL	Discontinued	none

Recall Notices

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover (January 5)
National Brands Inc. Issues a Nationwide Recall of Topaz brand Wafer Rolls Because of Possible Health Risks (December 19)
FDA Announces Class I Recall of Ophthalmic Surgical Device
Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits; Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile (December 23)
KRC Food Trading Inc. Recall of Fish Cake Sushi (December 23)

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January 2009

UNI-DUR Detail

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