Details for New Drug Application (NDA): 210913
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NDA 210913 describes CEQUA, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CEQUA profile page.
The generic ingredient in CEQUA is cyclosporine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
The generic ingredient in CEQUA is cyclosporine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 210913
| Tradename: | CEQUA |
| Applicant: | Sun Pharm |
| Ingredient: | cyclosporine |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210913
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for 210913
Suppliers and Packaging for NDA: 210913
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEQUA | cyclosporine | SOLUTION;OPHTHALMIC | 210913 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-506 | 47335-506-96 | 6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE |
| CEQUA | cyclosporine | SOLUTION;OPHTHALMIC | 210913 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-507 | 47335-507-97 | 1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;OPHTHALMIC | Strength | 0.09% | ||||
| Approval Date: | Aug 14, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 28, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE). | ||||||||
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