Details for New Drug Application (NDA): 211909
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NDA 211909 describes CYCLOSPORINE, which is a drug marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Onesource Specialty, Qilu, Sandoz, Amneal, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Twi Pharms, Hikma, Padagis Us, Abbvie, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-one NDAs. It is available from eleven 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 211909
| Tradename: | CYCLOSPORINE |
| Applicant: | Amneal |
| Ingredient: | cyclosporine |
| Patents: | 0 |
Pharmacology for NDA: 211909
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 211909
Suppliers and Packaging for NDA: 211909
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | cyclosporine | EMULSION;OPHTHALMIC | 211909 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1023 | 69238-1023-3 | 3 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE |
| CYCLOSPORINE | cyclosporine | EMULSION;OPHTHALMIC | 211909 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1023 | 69238-1023-6 | 6 POUCH in 1 CARTON (69238-1023-6) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;OPHTHALMIC | Strength | 0.05% | ||||
| Approval Date: | Nov 28, 2025 | TE: | AB | RLD: | No | ||||
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