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Details for New Drug Application (NDA): 206627

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NDA 206627 describes HYSINGLA, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are twenty patents protecting this drug and two Paragraph IV challenges. Additional details are available on the HYSINGLA profile page.

The generic ingredient in HYSINGLA 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: 206627

Tradename:
HYSINGLA
Applicant:
Purdue Pharma Lp
Ingredient:
hydrocodone bitartrate
Patents:20
Formulation / Manufacturing:see details

Pharmacology for NDA: 206627

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 206627

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL 206627 NDA Purdue Pharma LP 59011-271 59011-271-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60)
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL 206627 NDA Purdue Pharma LP 59011-272 59011-272-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Nov 20, 2014TE:RLD:Yes
Patent:6,488,963Patent Expiration:Jun 24, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:8,361,499Patent Expiration:Oct 30, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,529,948Patent Expiration:Aug 6, 2022Product 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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