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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076468

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NDA 076468 describes ANAGRELIDE HYDROCHLORIDE, which is a drug marketed by Barr, Impax Labs, Ivax Sub Teva Pharms, Mylan Pharms Inc, Roxane, Torrent Pharms Ltd, Upsher-smith Labs, and Watson Labs, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the ANAGRELIDE HYDROCHLORIDE profile page.

The generic ingredient in ANAGRELIDE HYDROCHLORIDE is anagrelide hydrochloride. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the anagrelide hydrochloride profile page.

Summary for 076468

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076468

Suppliers and Packaging for NDA: 076468

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANAGRELIDE HYDROCHLORIDE anagrelide hydrochloride CAPSULE;ORAL 076468 ANDA Teva Pharmaceuticals USA, Inc 0172-5240 0172-5240-60 100 CAPSULE in 1 BOTTLE (0172-5240-60)
ANAGRELIDE HYDROCHLORIDE anagrelide hydrochloride CAPSULE;ORAL 076468 ANDA Teva Pharmaceuticals USA, Inc 0172-5241 0172-5241-60 100 CAPSULE in 1 BOTTLE (0172-5241-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Apr 18, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Apr 18, 2005TE:ABRLD:No


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