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Details for New Drug Application (NDA): 202020

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NDA 202020 describes RAYOS, which is a drug marketed by Horizon Pharma and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RAYOS profile page.

The generic ingredient in RAYOS is prednisone. There are fifteen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for NDA: 202020

Tradename:
RAYOS
Applicant:
Horizon Pharma
Ingredient:
prednisone
Patents:7
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202020

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL 202020 NDA Horizon Pharma Inc. 75987-020 75987-020-01 1 BOTTLE in 1 CARTON (75987-020-01) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL 202020 NDA Horizon Pharma Inc. 75987-020 75987-020-02 1 BOTTLE in 1 CARTON (75987-020-02) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength1MG
Approval Date:Jul 26, 2012TE:RLD:No
Regulatory Exclusivity Expiration:Jul 26, 2015
Regulatory Exclusivity Use:CLINICAL TRIAL STUDY RESULTS
Patent:8,309,124Patent Expiration:Apr 23, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG PREDNISONE TABLET
Patent:8,394,407Patent Expiration:Apr 23, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET


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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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