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REVIEW ARTICLE
Year : 2014  |  Volume : 9  |  Issue : 2  |  Page : 79-84

Bioequivalence comparison of generic drug DuLocap and brand drug Cymbalta


Department of Quality Assurnace and Regulatory Affairs, L. J. Institute of Pharmacy, Ahmedabad, Gujarat, India

Correspondence Address:
M Mudaliar
L. J. Institute of Pharmacy, Near Nagdev Kalyan Temple, Sanand Sarkhej Cross Roads, Ahmedabad 388 210, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/9783-1230.139169

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Abbreviated new drug application is required to submit to United States Food and Drug Administration for approval of the generic version of an innovator drug. This application is for (DuLocap) ® duloxetine hydrochloride delayed release (DR) capsules 60 mg manufactured by alpha pharmaceuticals. This application is an abridged application claiming essential similarity to the brand product that is, Cymbalta ® (duloxetine HCL DR capsules) 60 mg, mfg by Lily S.A, Spain and marketed by Eli Lilly, This is application is filed on the basis of para III (patent expires on June 11, 2013).


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