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Generated: May 26, 2017

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Details for New Drug Application (NDA): 208010

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NDA 208010 describes RAYALDEE, which is a drug marketed by Opko Ireland Global and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the RAYALDEE profile page.

The generic ingredient in RAYALDEE is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.

Summary for NDA: 208010

Formulation / Manufacturing:see details

Pharmacology for NDA: 208010


Suppliers and Packaging for NDA: 208010

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE, EXTENDED RELEASE;ORAL 208010 NDA OPKO Pharmaceuticals LLC 70301-1001 70301-1001-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)
CAPSULE, EXTENDED RELEASE;ORAL 208010 NDA OPKO Pharmaceuticals LLC 70301-1001 70301-1001-2 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength0.03MG
Approval Date:Jun 17, 2016TE:RLD:Yes
Patent:6,582,727Patent Expiration:Aug 22, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:8,361,488Patent Expiration:Jul 19, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,906,410Patent Expiration:Feb 2, 2027Product 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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