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Generated: November 15, 2018

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Details for New Drug Application (NDA): 050716

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NDA 050716 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. Thirteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 050716
Tradename:NEORAL
Applicant:Novartis
Ingredient:cyclosporine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 050716
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEORAL cyclosporine SOLUTION;ORAL 050716 NDA Novartis Pharmaceuticals Corporation 0078-0274 0078-0274-22 1 BOTTLE in 1 CARTON (0078-0274-22) > 50 mL in 1 BOTTLE

Profile for product number 001

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

Expired US Patents for NDA 050716

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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