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Details for New Drug Application (NDA): 021264

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NDA 021264 describes APOKYN, which is a drug marketed by Us Worldmeds and is included in one NDA. It is available from two suppliers. Additional details are available on the APOKYN profile page.

The generic ingredient in APOKYN is apomorphine hydrochloride. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apomorphine hydrochloride profile page.

Summary for NDA: 021264

Tradename:
APOKYN
Applicant:
Us Worldmeds
Ingredient:
apomorphine hydrochloride
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021264

Mechanism of ActionDopamine Agonists

Suppliers and Packaging for NDA: 021264

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APOKYN
apomorphine hydrochloride
INJECTABLE;SUBCUTANEOUS 021264 NDA Tercica, Inc. 15054-0211 15054-0211-5 5 CARTRIDGE in 1 CARTON (15054-0211-5) > 3 mL in 1 CARTRIDGE (15054-0211-1)
APOKYN
apomorphine hydrochloride
INJECTABLE;SUBCUTANEOUS 021264 NDA US WorldMeds, LLC 27505-004 27505-004-05 5 CARTRIDGE in 1 CARTON (27505-004-05) > 3 mL in 1 CARTRIDGE (27505-004-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength20MG/2ML (10MG/ML)
Approval Date:Apr 20, 2004TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/3ML (10MG/ML)
Approval Date:Apr 20, 2004TE:RLD:Yes


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