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Details for New Drug Application (NDA): 206406

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NDA 206406 describes ENVARSUS XR, which is a drug marketed by Veloxis Pharms Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the ENVARSUS XR profile page.

The generic ingredient in ENVARSUS XR is tacrolimus. There are eighteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for NDA: 206406

Tradename:
ENVARSUS XR
Applicant:
Veloxis Pharms Inc
Ingredient:
tacrolimus
Patents:12
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 206406

Mechanism of ActionCalcineurin Inhibitors

Suppliers and Packaging for NDA: 206406

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL 206406 NDA Veloxis Pharmaceuticals, Inc 68992-3010 68992-3010-1 1 POUCH in 1 CARTON (68992-3010-1) > 1 BOTTLE in 1 POUCH > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL 206406 NDA Veloxis Pharmaceuticals, Inc 68992-3010 68992-3010-3 1 POUCH in 1 CARTON (68992-3010-3) > 1 BOTTLE, PLASTIC in 1 POUCH > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 0.75MG BASE
Approval Date:Jul 10, 2015TE:RLD:No
Patent:7,994,214Patent Expiration:Aug 30, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,591,946Patent Expiration:Aug 30, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,617,599Patent Expiration:Aug 30, 2024Product 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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