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Generated: December 16, 2018

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Details for New Drug Application (NDA): 050715

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NDA 050715 describes NEORAL, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the NEORAL profile page.

The generic ingredient in NEORAL is cyclosporine. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 050715
Tradename:NEORAL
Applicant:Novartis
Ingredient:cyclosporine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 050715
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEORAL cyclosporine CAPSULE;ORAL 050715 NDA Novartis Pharmaceuticals Corporation 0078-0246 0078-0246-15 30 BLISTER PACK in 1 CARTON (0078-0246-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)
NEORAL cyclosporine CAPSULE;ORAL 050715 NDA Novartis Pharmaceuticals Corporation 0078-0248 0078-0248-15 30 BLISTER PACK in 1 CARTON (0078-0248-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0248-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jul 14, 1995TE:AB1RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 14, 1995TE:AB1RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 14, 1995TE:RLD:Yes

Expired US Patents for NDA 050715

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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