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Details for New Drug Application (NDA): 065133

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NDA 065133 describes CYCLOSPORINE, which is a drug marketed by West-ward Pharms Int, Ivax Sub Teva Pharms, Sandoz, Abbvie, Wockhardt, Apotex, Mayne Pharma, Luitpold, and Apotex Inc, and is included in eleven NDAs. It is available from twelve suppliers. Additional details are available on the CYCLOSPORINE profile page.

The generic ingredient in CYCLOSPORINE 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: 065133

Therapeutic Class:Immunological Agents
Ophthalmic Agents

Suppliers and Packaging for NDA: 065133

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 065133 ANDA Morton Grove Pharmaceuticals, Inc. 60432-140 60432-140-50 50 mL in 1 BOTTLE (60432-140-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Sep 17, 2004TE:AB2RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.