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Generated: November 19, 2017

DrugPatentWatch Database Preview

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 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. Thirteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Summary for 050715

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Immunological Agents
Ophthalmic Agents
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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 050715

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-002Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-001Jul 14, 1995► Subscribe► Subscribe
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715-003Jul 14, 1995► Subscribe► Subscribe
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