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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-two suppliers are listed for this compound. There are nine tentative approvals for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for NDA: 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

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 10147-0891-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10147-0891-3)
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL 021615 NDA Patriot Pharmaceuticals, LLC 10147-0892 10147-0892-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10147-0892-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:7,160,559Patent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:No
Patent:7,160,559Patent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:No
Patent:7,160,559Patent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book 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;ORAL021615-001Apr 1, 20054,663,318► subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-003Apr 1, 20054,663,318► subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-002Apr 1, 20054,663,318► subscribe
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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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