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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 two suppliers. Additional details are available on the NEORAL profile page.

The generic ingredient in NEORAL is cyclosporine. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Summary for NDA: 050716

Tradename:
NEORAL
Applicant:
Novartis
Ingredient:
cyclosporine
Patents:0
Therapeutic Class:Immunological Agents
Ophthalmic Agents
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 050716

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
NEORAL
cyclosporine
SOLUTION;ORAL050716-001Jul 14, 19956,258,808► subscribe
Novartis
NEORAL
cyclosporine
SOLUTION;ORAL050716-001Jul 14, 19955,985,321► subscribe
Novartis
NEORAL
cyclosporine
SOLUTION;ORAL050716-001Jul 14, 19956,007,840► subscribe
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