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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Johnson and Johnson

Generated: December 15, 2017

DrugPatentWatch Database Preview

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 021264

Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021264

Mechanism of ActionDopamine Agonists

Medical Subject Heading (MeSH) Categories for 021264

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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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