Application 212461

Type
ANDA
Sponsor
INTL MEDICATION SYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINE SULFATEATROPINE SULFATESOLUTION;INTRAVENOUS1MG/10ML (0.1MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5924Atropine SulfateAtropine SulfateA-S Medication SolutionsANDACurrent
51662-1527ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
70518-3120Atropine SulfateAtropine SulfateREMEDYREPACK INC.ANDACurrent
71872-7252Atropine SulfateAtropine SulfateMedical Purchasing Solutions, LLCANDACurrent
76329-3340Atropine SulfateAtropine SulfateInternational Medication Systems, LimitedANDACurrent
76329-3340Atropine SulfateAtropine SulfateInternational Medication Systems, LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65507ORIG2020-12-07