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Application 207986

Type
NDA
Sponsor
OTONOMY INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTIPRIOCIPROFLOXACININJECTABLE, SUSPENSION;OTIC6% (60MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0268-8200OTIPRIOOTIPRIOALK-Abello, Inc.NDACurrent
0268-8200OTIPRIOOTIPRIOALK-Abello, Inc.NDACurrent
69251-201OtipriociprofloxacinOtonomy, Inc.NDACurrent
69251-201OtipriociprofloxacinOtonomy, Inc.NDACurrent
69251-201OtipriociprofloxacinOtonomy, Inc.NDACurrent
69251-201OtipriociprofloxacinOtonomy, Inc.NDACurrent
69251-201OtipriociprofloxacinOtonomy, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53009SUPPL2018-03-15
52820SUPPL2018-03-06
44968ORIG2016-02-19
43540ORIG2016-02-19
40607SUPPL2016-02-18
32873SUPPL2016-01-28
40606ORIG2015-12-15
10639ORIG2015-12-14
52576ORIG1900-01-01
52575ORIG1900-01-01
52574ORIG1900-01-01
52573ORIG1900-01-01