FDA.reportPublic FDA data

Application 207534

Type
NDA
Sponsor
ADAMIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMJEPIEPINEPHRINESOLUTION;INTRAMUSCULAR, SUBCUTANEOUS0.3MG/0.3ML (0.3MG/0.3ML)YesYes
002SYMJEPIEPINEPHRINESOLUTION;INTRAMUSCULAR, SUBCUTANEOUS0.15MG/0.3ML (0.15MG/0.3ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3442SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3442SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3442SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3442SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3442SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3448SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3448SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3448SYMJEPIEpinephrineSandoz Inc.NDACurrent
0781-3448SYMJEPIEpinephrineSandoz Inc.NDACurrent
38739-200SYMJEPIEpinephrineAdamis Pharmaceuticals CorporationNDACurrent
78670-130SymjepiepinephrineUSWM, LLCNDACurrent
78670-130SymjepiepinephrineUSWM, LLCNDACurrent
78670-130SymjepiepinephrineUSWM, LLCNDACurrent
78670-130SymjepiepinephrineUSWM, LLCNDACurrent
78670-131SymjepiepinephrineUSWM, LLCNDACurrent
78670-131SymjepiepinephrineUSWM, LLCNDACurrent
78670-131SymjepiepinephrineUSWM, LLCNDACurrent
78670-131SymjepiepinephrineUSWM, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67987SUPPL2021-06-30
67981SUPPL2021-06-30
64424SUPPL2020-08-27
55804SUPPL2018-10-03
55753SUPPL2018-10-01
49517ORIG2017-08-23
48731ORIG2017-06-16
48725ORIG2017-06-15