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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021615

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NDA 021615 describes RAZADYNE ER, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RAZADYNE ER profile page.

The generic ingredient in RAZADYNE ER is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 021615
Tradename:RAZADYNE ER
Applicant:Janssen Pharms
Ingredient:galantamine hydrobromide
Patents:1
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021615
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 021615
Suppliers and Packaging for NDA: 021615
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615 NDA Patriot Pharmaceuticals, LLC 10147-0891 N 10147-0891-3
RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615 NDA Patriot Pharmaceuticals, LLC 10147-0892 N 10147-0892-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021615

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
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Julphar
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