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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050625

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NDA 050625 describes SANDIMMUNE, which is a drug marketed by Novartis and is included in three NDAs. It is available from one supplier. Additional details are available on the SANDIMMUNE profile page.

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

Summary for 050625

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Immunological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 050625

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SANDIMMUNE cyclosporine CAPSULE;ORAL 050625 NDA Novartis Pharmaceuticals Corporation 0078-0240 0078-0240-15 30 BLISTER PACK in 1 PACKAGE (0078-0240-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0240-61)
SANDIMMUNE cyclosporine CAPSULE;ORAL 050625 NDA Novartis Pharmaceuticals Corporation 0078-0241 0078-0241-15 30 BLISTER PACK in 1 PACKAGE (0078-0241-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0241-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Mar 2, 1990TE:AB2RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 2, 1990TE:AB2RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Nov 23, 1992TE:BXRLD:Yes

Expired Orange Book Patents for NDA: 050625

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisSANDIMMUNEcyclosporineCAPSULE;ORAL050625-001Mar 2, 1990► Subscribe► Subscribe
NovartisSANDIMMUNEcyclosporineCAPSULE;ORAL050625-003Nov 23, 1992► Subscribe► Subscribe
NovartisSANDIMMUNEcyclosporineCAPSULE;ORAL050625-002Mar 2, 1990► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
US Army
Mallinckrodt
Moodys
Chinese Patent Office
UBS
Boehringer Ingelheim
Citi
Colorcon

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