FDA.reportPublic FDA data

Application 214652

Type
NDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINE SULFATEATROPINE SULFATESOLUTION; INJECTION0.4MG/MLNoNo
002ATROPINE SULFATEATROPINE SULFATESOLUTION; INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-525ATROPINE SULFATEATROPINE SULFATEAccord Healthcare Inc.NDACurrent
16729-525ATROPINE SULFATEATROPINE SULFATEAccord Healthcare Inc.NDACurrent
16729-526Atropine SulfateATROPINE SULFATEAccord Healthcare Inc.NDACurrent
16729-526Atropine SulfateATROPINE SULFATEAccord Healthcare Inc.NDACurrent
71872-7245Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCNDACurrent
71872-7245Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCNDACurrent
71872-7246ATROPINE SULFATEATROPINE SULFATEMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84925SUPPL 2026-02-05
84924SUPPL 2026-02-05
81288SUPPL 2025-02-19
66245ORIG2021-02-17
64767ORIG2020-09-30
64765ORIG2020-09-30