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Generated: November 18, 2018

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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 four 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-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 075135
Tradename:PACERONE
Applicant:Upsher-smith Labs
Ingredient:amiodarone hydrochloride
Patents:0
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, LLC 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, LLC 0245-0144 0245-0144-11 100 TABLET in 1 BOTTLE (0245-0144-11)

Profile for product number 001

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

Profile for product number 002

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

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Colorcon

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