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Details for New Drug Application (NDA): 021450

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NDA 021450 describes ZOMIG, which is a drug marketed by Astrazeneca and IPR and is included in three NDAs. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZOMIG profile page.

The generic ingredient in ZOMIG is zolmitriptan. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

Summary for NDA: 021450

Tradename:
ZOMIG
Applicant:
Astrazeneca
Ingredient:
zolmitriptan
Patents:2
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021450

Suppliers and Packaging for NDA: 021450

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOMIG
zolmitriptan
SPRAY;NASAL 021450 NDA Rebel Distributors Corp 21695-955 21695-955-06 6 BOTTLE, SPRAY in 1 CARTON (21695-955-06) > 1 SPRAY, METERED in 1 BOTTLE, SPRAY
ZOMIG
zolmitriptan
SPRAY;NASAL 021450 NDA Impax Specialty Pharma 64896-681 64896-681-30 1 BOTTLE, SPRAY in 1 CARTON (64896-681-30) > 1 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrength2.5MG/SPRAY
Approval Date:Sep 16, 2013TE:RLD:No
Patent:6,750,237*PEDPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:7,220,767*PEDPatent Expiration:May 28, 2021Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Jun 12, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 021450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ZOMIG
zolmitriptan
SPRAY;NASAL021450-004Sep 30, 20035,466,699*PED► 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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