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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 065044


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NDA 065044 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in eighteen NDAs. It is available from ten suppliers. Additional details are available on the CYCLOSPORINE profile page.

The generic ingredient in CYCLOSPORINE is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 065044
Tradename:CYCLOSPORINE
Applicant:Dr Reddys Labs Sa
Ingredient:cyclosporine
Patents:0
Suppliers and Packaging for NDA: 065044
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOSPORINE cyclosporine CAPSULE;ORAL 065044 ANDA Mayne Pharma Inc. 51862-458 51862-458-47 30 BLISTER PACK in 1 BOX (51862-458-47) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-458-01)
CYCLOSPORINE cyclosporine CAPSULE;ORAL 065044 ANDA Mayne Pharma Inc. 51862-460 51862-460-47 30 BLISTER PACK in 1 BOX (51862-460-47) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-460-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 20, 2000TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 20, 2000TE:AB1RLD:No

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