Details for New Drug Application (NDA): 205894
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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 205894
Tradename: | CYCLOSPORINE |
Applicant: | Mylan |
Ingredient: | cyclosporine |
Patents: | 0 |
Pharmacology for NDA: 205894
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 205894
Suppliers and Packaging for NDA: 205894
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | cyclosporine | EMULSION;OPHTHALMIC | 205894 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8760 | 0378-8760-58 | 6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USE |
CYCLOSPORINE | cyclosporine | EMULSION;OPHTHALMIC | 205894 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8760 | 0378-8760-91 | 12 POUCH in 1 CARTON (0378-8760-91) / 5 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: | Feb 2, 2022 | TE: | AB | RLD: | No |
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