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Generated: March 19, 2019

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Details for New Drug Application (NDA): 210913

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NDA 210913 describes CEQUA, which is a drug marketed by Sun Pharma Global and is included in one NDA. It is available from one supplier. There are two 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. Eleven suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
Summary for 210913
Tradename:CEQUA
Applicant:Sun Pharma Global
Ingredient:cyclosporine
Patents:2
Formulation / Manufacturing:see details
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:RXDosage:SOLUTION;OPHTHALMICStrength0.09%
Approval Date:Aug 14, 2018TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 23, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
Patent:➤ Sign UpPatent Expiration:Aug 23, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).

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