Details for New Drug Application (NDA): 065044
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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 |
Pharmacology for NDA: 065044
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 065044
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 20, 2000 | TE: | AB1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 20, 2000 | TE: | AB1 | RLD: | No |
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