FDA.reportPublic FDA data

Application 212909

Type
NDA
Sponsor
ETON PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIORPHENPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS0.1MG/ML (0.1MG/ML)YesYes
002BIORPHENPHENYLEPHRINE HYDROCHLORIDESOLUTION;INTRAVENOUS10MG/ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-172BiorphenPhenylephrine hydrochlorideDr. Reddy's Laboratories Inc.NDACurrent
43598-199BiorphenPhenylephrine hydrochlorideDr. Reddy's Laboratories Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-202BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-203BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent
71863-208BiorphenPhenylephrine hydrochlorideEton Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80510SUPPL 2024-12-05
80500SUPPL 2024-12-04
66755SUPPL2021-03-12
66752SUPPL2021-03-12
62357ORIG2020-03-30
60633ORIG2019-10-23
60626ORIG2019-10-22