Atropine Ophthalmic Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2015-01-08)
Oldest Current Product
1990-09-30
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
OPHTHALMIC SOLUTION\ATROPINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\ATROPINE SULFATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\ATROPINE SULFATE
OPHTHALMIC\SOLUTION\ATROPINE SULFATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\ATROPINE
OPHTHALMIC\SOLUTION\ATROPINE

product(s) by strength(s)

atropine sulfate 10 mg/ml ophthalmic solution

original product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1174780215NDAAkorn2014-07-18ATROPINE SULFATEOPHTHALMICSOLUTION/DROPSNDA206289f7b40bf1-3063-4849-a5a0-0ac5d0d1e72a
2242080750UNAPPROVED DRUG OTHER MARKETING CATEGORYBausch & Lomb Incorporated1990-09-302016-09-30ATROPINE SULFATEOPHTHALMICSOLUTION37ace98a-994d-45fc-8241-c468abb4f7eb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1521250527UNAPPROVED DRUG OTHER MARKETING CATEGORYRemedyrepack Inc.2015-08-20ATROPINE SULFATEOPHTHALMICSOLUTION242080750ffd0dbf2-f5c0-4052-908f-289a2ee01970
2545692784UNAPPROVED DRUG OTHER MARKETING CATEGORYA-S Medication Solutions Llc1990-09-30ATROPINE SULFATEOPHTHALMICSOLUTION24208075031e608aa-f552-4c49-bf12-7da0963c62b1

application(s)

#idtitleapplicantapprovedapproved drug
1NDA206289ATROPINE SULFATEAKORN INC2014-07-18NDA206289_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206289_001RXATROPINE SULFATE (1%)OPHTHALMICSOLUTION/DROPSTrue2014-07-18ATROPINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
131e608aa-f552-4c49-bf12-7da0963c62b1 (view SPL)Atropine Sulfate Ophthalmic Solution USP, 1% (Sterile) Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-251545692784
237ace98a-994d-45fc-8241-c468abb4f7eb (view SPL)Atropine Sulfate Ophthalmic Solution USP, 1% (Sterile) Rx onlyprescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2015-01-086242080750
3590a4e7b-565f-415f-a8e4-499a382c9a3b (view SPL)These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%.Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye.Initial U.S. Approval: 1960prescriptionHuman PrescriptionMwiANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-03-231139850606
46fdb0fa2-83bd-4d23-bf66-267b10f3121a (view SPL)Atropine Sulfate Ophthalmic Solution, 1%prescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-09-231613140303
5f7b40bf1-3063-4849-a5a0-0ac5d0d1e72a (view SPL)These highlights do not include all the information needed to use Atropine Sulfate Ophthalmic Solution, USP 1% safely and effectively. See full prescribing information for Atropine Sulfate Ophthalmic Solution, USP 1%.Atropine Sulfate Ophthalmic Solution, USP 1% for topical application to the eye.Initial U.S. Approval: 1960prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-157174780215
6ffd0dbf2-f5c0-4052-908f-289a2ee01970 (view SPL)Atropine Sulfate Ophthalmic Solution USP, 1% (Sterile)Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-08-201521250527

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII