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Last Updated: May 24, 2022

Details for New Drug Application (NDA): 021560


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NDA 021560 describes ZORTRESS, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the ZORTRESS profile page.

The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the everolimus profile page.
Summary for 021560
Tradename:ZORTRESS
Applicant:Novartis
Ingredient:everolimus
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORTRESS everolimus TABLET;ORAL 021560 NDA Novartis Pharmaceuticals Corporation 0078-0414 0078-0414-20 60 BLISTER PACK in 1 BOX (0078-0414-20) > 1 TABLET in 1 BLISTER PACK (0078-0414-61)
ZORTRESS everolimus TABLET;ORAL 021560 NDA Novartis Pharmaceuticals Corporation 0078-0415 0078-0415-20 60 BLISTER PACK in 1 BOX (0078-0415-20) > 1 TABLET in 1 BLISTER PACK (0078-0415-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Apr 20, 2010TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 20, 2010TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.75MG
Approval Date:Apr 20, 2010TE:ABRLD:Yes

Expired US Patents for NDA 021560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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