FDA.reportPublic FDA data

Application 213581

Type
NDA
Sponsor
PARAGON BIOTECK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINE SULFATEATROPINE SULFATESOLUTION; OPHTHALMIC10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-965Atropine SulfateAtropine SulfateBausch & Lomb IncorporatedNDACurrent
24208-965Atropine SulfateAtropine SulfateBausch & Lomb IncorporatedNDACurrent
24208-965Atropine SulfateAtropine SulfateBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72506ORIG2022-10-31
70535ORIG2022-03-16
70529ORIG2022-03-16