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Details for New Drug Application (NDA): 202880

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NDA 202880 describes ZOHYDRO ER, which is a drug marketed by Pernix Ireland Pain and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZOHYDRO ER profile page.

The generic ingredient in ZOHYDRO ER is hydrocodone bitartrate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Summary for NDA: 202880

Tradename:
ZOHYDRO ER
Applicant:
Pernix Ireland Pain
Ingredient:
hydrocodone bitartrate
Patents:10
Formulation / Manufacturing:see details

Pharmacology for NDA: 202880

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 202880

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL 202880 NDA Zogenix, Inc. 43376-210 43376-210-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43376-210-10)
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL 202880 NDA Zogenix, Inc. 43376-215 43376-215-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43376-215-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:6,228,398Patent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:6,902,742Patent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:9,132,096Patent Expiration:Sep 12, 2034Product Flag?YSubstance Flag?Delist Request?


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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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