FDA.reportPublic FDA data

Application 021146

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINE SULFATE ANSYR PLASTIC SYRINGEATROPINE SULFATESOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ATROPINE SULFATE ANSYR PLASTIC SYRINGEATROPINE SULFATESOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL0.25MG/5ML (0.05MG/ML)YesYes
003ATROPINE SULFATE ANSYR PLASTIC SYRINGEATROPINE SULFATESOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL1MG/10ML (0.1MG/ML)YesYes
004ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGEATROPINE SULFATESOLUTION;INTRAVENOUS0.5MG/5ML (0.1MG/ML)YesYes
005ATROPINE SULFATE LIFESHIELD ABBOJECT SYRINGEATROPINE SULFATESOLUTION;INTRAVENOUS1MG/10ML (0.1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9823Atropine SulfateAtropine SulfateHenry Schein, Inc.NDACurrent
0404-9823Atropine SulfateAtropine SulfateHenry Schein, Inc.NDACurrent
0404-9823Atropine SulfateAtropine SulfateHenry Schein, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-1630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4910Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4910Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4910Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4910Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4910ATROPINE SULFATEATROPINE SULFATEHospira, Inc.NDACurrent
0409-4910Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4911Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4911ATROPINE SULFATEATROPINE SULFATEHospira, Inc.NDACurrent
0409-4911Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4911Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4911Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-4911Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
0409-9630Atropine SulfateATROPINE SULFATEHospira, Inc.NDACurrent
50090-2181ATROPINE SULFATEATROPINE SULFATEA-S Medication SolutionsNDACurrent
51662-1289ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1289ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1289ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1289ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1289ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1289ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
52584-630Atropine SulfateAtropine SulfateGeneral Injectables & Vaccines, Inc.NDACurrent
71872-7002Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCNDACurrent
71872-7002Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCNDACurrent
71872-7002Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83010SUPPL 2025-08-01
83007SUPPL 2025-07-31
65970SUPPL2021-01-25
65965SUPPL2021-01-25
63700SUPPL2020-06-25
63697SUPPL2020-06-25
57337SUPPL2019-01-23
50259SUPPL2017-11-02
47069SUPPL2017-01-31
14495SUPPL2015-11-04
4459SUPPL2015-11-04
21476ORIG2004-05-27
26899ORIG2001-07-09
14494ORIG2001-07-09