prednisolone Ophthalmic Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2013-09-12)
Oldest Current Product
1994-07-29
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\PREDNISOLONE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\PREDNISOLONE SODIUM PHOSPHATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\PREDNISOLONE SODIUM PHOSPHATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\PREDNISOLONE

product(s) by strength(s)

prednisolone 10 mg/ml ophthalmic solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1116951431ANDAButler Animal Health Supply1994-07-29PREDNISOLONE SODIUM PHOSPHATEOPHTHALMICSOLUTION/DROPSANDA04007021092699-6ba7-42d2-b148-66a669084bc6
2139850025ANDAMwi1994-07-29PREDNISOLONE SODIUM PHOSPHATEOPHTHALMICSOLUTION/DROPSANDA040070dbcab023-8a71-4c66-ac6b-b98b20a493f9
3242080715ANDABausch & Lomb Incorporated1994-07-29PREDNISOLONE SODIUM PHOSPHATEOPHTHALMICSOLUTION/DROPSANDA0400708a7f0f2a-3a48-4488-89cd-3e91c3b1365f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040065PREDNISOLONE SODIUM PHOSPHATETrueBAUSCH AND LOMB PHARMACEUTICALS INC1994-07-29ANDA040065_001
2ANDA040070PREDNISOLONE SODIUM PHOSPHATEBAUSCH AND LOMB PHARMACEUTICALS INC1994-07-29ANDA040070_001
3ANDA080751INFLAMASE FORTETrueNOVARTIS PHARMACEUTICALS CORPANDA080751_001, ANDA080751_002
4ANDA081043PREDNISOLONE SODIUM PHOSPHATETrueALCON PHARMACEUTICALS LTD1991-10-24ANDA081043_001
5ANDA081044PREDNISOLONE SODIUM PHOSPHATETrueALCON PHARMACEUTICALS LTD1991-10-24ANDA081044_001
6ANDA083358PREDNISOLONE SODIUM PHOSPHATETrueAKORN INCANDA083358_001, ANDA083358_002
7ANDA083834METRETONTrueSCHERING CORP SUB SCHERING PLOUGH CORPANDA083834_001
8ANDA084168PREDNISOLONE SODIUM PHOSPHATETrueSOLA BARNES HINDANDA084168_001
9ANDA084169PREDNISOLONE SODIUM PHOSPHATETrueSOLA BARNES HINDANDA084169_001
10ANDA084171PREDNISOLONE SODIUM PHOSPHATETrueSOLA BARNES HINDANDA084171_001
11ANDA084172PREDNISOLONE SODIUM PHOSPHATETrueSOLA BARNES HINDANDA084172_001
12ANDA088165PREDAIR FORTETruePHARMAFAIR INC1983-03-28ANDA088165_001
13ANDA088415PREDAIRTruePHARMAFAIR INC1984-02-29ANDA088415_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040065_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.11% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalse1994-07-29PREDNISOLONE SODIUM PHOSPHATE
2ANDA040070_001RXPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSTrue1994-07-29PREDNISOLONE SODIUM PHOSPHATE
3ANDA080751_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.11% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalseINFLAMASE FORTE
4ANDA080751_002discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalseINFLAMASE FORTE
5ANDA081043_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.11% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalse1991-10-24PREDNISOLONE SODIUM PHOSPHATE
6ANDA081044_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalse1991-10-24PREDNISOLONE SODIUM PHOSPHATE
7ANDA083358_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.11% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalsePREDNISOLONE SODIUM PHOSPHATE
8ANDA083358_002discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalsePREDNISOLONE SODIUM PHOSPHATE
9ANDA083834_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.5% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalseMETRETON
10ANDA084168_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalsePREDNISOLONE SODIUM PHOSPHATE
11ANDA084169_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalsePREDNISOLONE SODIUM PHOSPHATE
12ANDA084171_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.11% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalsePREDNISOLONE SODIUM PHOSPHATE
13ANDA084172_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalsePREDNISOLONE SODIUM PHOSPHATE
14ANDA088165_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.9% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalse1983-03-28PREDAIR FORTE
15ANDA088415_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.11% PHOSPHATE)OPHTHALMICSOLUTION/DROPSFalse1984-02-29PREDAIR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
121092699-6ba7-42d2-b148-66a669084bc6 (view SPL)Prednisolone Sodium PhosphateOphthalmic Solution USP, 1% (Sterile)prescriptionHuman PrescriptionButler Animal Health SupplyMANUFACTURE2010-11-041116951431
28a7f0f2a-3a48-4488-89cd-3e91c3b1365f (view SPL)Prednisolone Sodium Phosphate Ophthalmic Solution USP, 1% (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2013-09-124242080715
3dbcab023-8a71-4c66-ac6b-b98b20a493f9 (view SPL)Prednisolone Sodium PhosphateOphthalmic Solution USP, 1% (Sterile)prescriptionHuman PrescriptionMwiMANUFACTURE2010-11-041139850025

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