Application 207686

Type
ANDA
Sponsor
PRECISION DOSE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTOLAMINE MESYLATEPHENTOLAMINE MESYLATEINJECTABLE;INJECTION5MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51224-012Phentolamine MesylatePhentolamine MesylateTAGI Pharma, Inc.ANDACurrent
51224-012Phentolamine MesylatePhentolamine MesylateTAGI Pharma, Inc.ANDACurrent
51224-012Phentolamine MesylatePhentolamine MesylateTAGI Pharma, Inc.ANDACurrent
51224-012Phentolamine MesylatePhentolamine MesylateTAGI Pharma, Inc.ANDACurrent
68094-101PHENTOLAMINE MESYLATEPHENTOLAMINE MESYLATEPrecision Dose Inc.ANDACurrent
68094-101PHENTOLAMINE MESYLATEPHENTOLAMINE MESYLATEPrecision Dose Inc.ANDACurrent
68094-101PHENTOLAMINE MESYLATEPHENTOLAMINE MESYLATEPrecision Dose Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71465ORIG2022-06-28