Details for New Drug Application (NDA): 065003
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NDA 065003 describes GENGRAF, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the GENGRAF profile page.
The generic ingredient in GENGRAF 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.
The generic ingredient in GENGRAF 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 065003
| Tradename: | GENGRAF |
| Applicant: | Abbvie |
| Ingredient: | cyclosporine |
| Patents: | 0 |
Pharmacology for NDA: 065003
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 065003
Suppliers and Packaging for NDA: 065003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENGRAF | cyclosporine | CAPSULE;ORAL | 065003 | ANDA | AbbVie Inc. | 0074-3108 | 0074-3108-32 | 3 BLISTER PACK in 1 CARTON (0074-3108-32) / 10 CAPSULE in 1 BLISTER PACK |
| GENGRAF | cyclosporine | CAPSULE;ORAL | 065003 | ANDA | AbbVie Inc. | 0074-3109 | 0074-3109-32 | 5 BLISTER PACK in 1 CARTON (0074-3109-32) / 6 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | May 12, 2000 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | May 12, 2000 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | May 12, 2000 | TE: | AB1 | RLD: | No | ||||
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