Details for New Drug Application (NDA): 216046
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NDA 216046 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource Specialty, Qilu, Sandoz, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in nineteen 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 eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. 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. Twenty-one suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 216046
| Tradename: | CYCLOSPORINE |
| Applicant: | Onesource Specialty |
| Ingredient: | cyclosporine |
| Patents: | 0 |
Pharmacology for NDA: 216046
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 216046
Suppliers and Packaging for NDA: 216046
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 216046 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-837 | 23155-837-30 | 3 BLISTER PACK in 1 CARTON (23155-837-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-837-11) |
| CYCLOSPORINE | cyclosporine | CAPSULE;ORAL | 216046 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-838 | 23155-838-30 | 6 BLISTER PACK in 1 CARTON (23155-838-30) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-838-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 2, 2022 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Aug 2, 2022 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 2, 2022 | TE: | AB1 | RLD: | No | ||||
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