FDA.reportPublic FDA data

Application 205029

Type
NDA
Sponsor
BELCHER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPINEPHRINEEPINEPHRINESOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUSEQ 1MG BASE/ML (EQ 1MG BASE/ML)YesYes
002EPINEPHRINEEPINEPHRINESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS10MG/10ML (1MG/ML)YesNo
003EPINEPHRINEEPINEPHRINESOLUTION;INTRAVENOUS1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**YesNo
004EPINEPHRINEEPINEPHRINESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS30MG/30ML (1MG/ML)YesYes
005EPINEPHRINEEPINEPHRINESOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS1MG/ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9857EPINEPHRINEEPINEPHRINEHenry Schein, Inc.NDACurrent
0404-9857EPINEPHRINEEPINEPHRINEHenry Schein, Inc.NDACurrent
0404-9857EPINEPHRINEEPINEPHRINEHenry Schein, Inc.NDACurrent
50090-3039EpinephrineEpinephrineA-S Medication SolutionsNDACurrent
52584-103EPINEPHRINEEPINEPHRINEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-103EPINEPHRINEEPINEPHRINEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-103EPINEPHRINEEPINEPHRINEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-103EPINEPHRINEEPINEPHRINEGeneral Injectables and Vaccines, Inc.NDACurrent
52584-103EPINEPHRINEEPINEPHRINEGeneral Injectables and Vaccines, Inc.NDACurrent
54288-103EpinephrineEpinephrineBPI Labs, LLCNDACurrent
54288-103EpinephrineEpinephrineBPI Labs, LLCNDACurrent
54288-103EpinephrineEpinephrineBPI Labs, LLCNDACurrent
54288-103EpinephrineEpinephrineBPI Labs, LLCNDACurrent
54288-120EPINEPHRINEEPINEPHRINEBPI Labs, LLCNDACurrent
54288-120EPINEPHRINEEPINEPHRINEBPI Labs, LLCNDACurrent
62250-102EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
62250-103EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
62250-103EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
62250-103EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
62250-103EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
62250-103EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
62250-103EPINEPHRINEEPINEPHRINEBelcher Pharmaceuticals, LLCNDACurrent
70518-1215EpinephrineEpinephrineREMEDYREPACK INC.NDACurrent
70518-1215EpinephrineEpinephrineREMEDYREPACK INC.NDACurrent
70518-1215EpinephrineEpinephrineREMEDYREPACK INC.NDACurrent
70518-1215EpinephrineEpinephrineREMEDYREPACK INC.NDACurrent
71872-7117EpinephrineEpinephrineMedical Purchasing Solutions, LLCNDACurrent
71872-7117EpinephrineEpinephrineMedical Purchasing Solutions, LLCNDACurrent
71872-7117EpinephrineEpinephrineMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83605SUPPL 2025-09-30
83602SUPPL 2025-09-30
82739SUPPL 2025-07-07
82709SUPPL 2025-06-30
78408SUPPL 2024-05-07
78407SUPPL 2024-05-07
77605SUPPL 2024-02-23
77603SUPPL 2024-02-23
74249SUPPL 2023-05-15
74242SUPPL 2023-05-15
73864SUPPL 2023-04-04
73865SUPPL 2023-03-27
68622SUPPL2021-09-15
68594SUPPL2021-09-13
67925SUPPL2021-06-28
67898SUPPL2021-06-24
40434SUPPL2016-05-20
10415SUPPL2016-05-19
40433SUPPL2016-02-18
32618SUPPL2016-02-12
19616SUPPL2015-10-27
32617SUPPL2015-10-26
43482ORIG2015-03-31
19615ORIG2014-08-14
32616ORIG2014-07-31