Metipranolol Ophthalmic Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2011-08-09)
Oldest Current Product
2001-08-09
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\METIPRANOLOL
FDAOB
OPHTHALMIC\SOLUTION_DROPS\METIPRANOLOL HYDROCHLORIDE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\METIPRANOLOL
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\METIPRANOLOL

product(s) by strength(s)

metipranolol 3 mg/ml ophthalmic solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1613140447ANDASandoz Inc2001-08-09METIPRANOLOLOPHTHALMICSOLUTION/DROPSANDA075720699ce415-0798-4244-b5ec-bcdb383b50b3

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075720METIPRANOLOLALCON RESEARCH LTD2001-08-06ANDA075720_001
2NDA019907OPTIPRANOLOLBAUSCH AND LOMB PHARMACEUTICALS INC1989-12-29NDA019907_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075720_001RXMETIPRANOLOL HYDROCHLORIDE (0.3%)OPHTHALMICSOLUTION/DROPSFalseAT2001-08-06METIPRANOLOL
2NDA019907_001RXMETIPRANOLOL HYDROCHLORIDE (0.3%)OPHTHALMICSOLUTION/DROPSTrueAT1989-12-29OPTIPRANOLOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1699ce415-0798-4244-b5ec-bcdb383b50b3 (view SPL)Metipranolol Ophthalmic Solution 0.3% Sterile Ophthalmic Solution Rx OnlyprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-08-092613140447

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