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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075135

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NDA 075135 describes PACERONE, which is a drug marketed by Upsher-smith Labs and is included in one NDA. It is available from six suppliers. Additional details are available on the PACERONE profile page.

The generic ingredient in PACERONE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for 075135

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075135

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACERONE amiodarone hydrochloride TABLET;ORAL 075135 ANDA Upsher-Smith Laboratories, Inc. 0245-0144 0245-0144-01 100 BLISTER PACK in 1 CARTON (0245-0144-01) > 1 TABLET in 1 BLISTER PACK (0245-0144-89)
PACERONE amiodarone hydrochloride TABLET;ORAL 075135 ANDA Upsher-Smith Laboratories, Inc. 0245-0144 0245-0144-11 100 TABLET in 1 BOTTLE (0245-0144-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Apr 30, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 12, 2005TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Healthtrust
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Medtronic

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