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Generated: October 17, 2018

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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 fourteen 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-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
Summary for 202880
Tradename:ZOHYDRO ER
Applicant:Pernix Ireland Pain
Ingredient:hydrocodone bitartrate
Patents:14
Formulation / Manufacturing:see details
Pharmacology for NDA: 202880
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 202880
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 25, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Patent:➤ Sign UpPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?

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