Application 208694

Type
NDA
Sponsor
EYEVANCE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ZERVIATECETIRIZINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.24% BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent
71776-024ZerviateCetirizineEyevance PharmaceuticalsNDACurrent

Documents

DocumentSubmission typeDate
61847SUPPL2020-02-07
61806SUPPL2020-02-06
54734ORIG2018-07-02
54733ORIG2018-07-02
52420ORIG2018-01-01
48628ORIG2017-06-02
48612ORIG2017-06-01
51478ORIG2016-03-29
51477ORIG2015-09-15
52419ORIG1900-01-01
52418ORIG1900-01-01
52417ORIG1900-01-01