prednisolone / Sulfacetamide Ophthalmic Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2014-02-10)
Oldest Current Product
1995-12-29
License(s)
ANDA
RxNORM
OPHTHALMIC SOLUTION\PREDNISOLONE:SULFACETAMIDE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\PREDNISOLONE SODIUM PHOSPHATE: SULFACETAMIDE SODIUM
SPL Active
OPHTHALMIC\SOLUTION/DROPS\PREDNISOLONE SODIUM PHOSPHATE: SULFACETAMIDE SODIUM
OPHTHALMIC\SOLUTION\PREDNISOLONE SODIUM PHOSPHATE: SULFACETAMIDE SODIUM
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\PREDNISOLONE: SULFACETAMIDE
OPHTHALMIC\SOLUTION\PREDNISOLONE: SULFACETAMIDE

product(s) by strength(s)

prednisolone sodium phosphate 2.5 mg/ml / sulfacetamide sodium 100 mg/ml ophthalmic solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080317ANDABausch & Lomb Incorporated1995-12-29PREDNISOLONE SODIUM PHOSPHATE, SULFACETAMIDE SODIUMOPHTHALMICSOLUTION/DROPSANDA0744499ec403eb-b5df-4e41-9e17-9d9d8ecac3f3
2613140297ANDASandoz Inc2004-03-09PREDNISOLONE SODIUM PHOSPHATE, SULFACETAMIDE SODIUMOPHTHALMICSOLUTIONANDA073630ad1f288e-b2cc-4933-b12a-b034faa84fe4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950186ANDARebel Distributors Corp1995-12-29PREDNISOLONE SODIUM PHOSPHATE, SULFACETAMIDE SODIUMOPHTHALMICSOLUTION613140297ANDA074449e5a2f3a5-2b9d-4d02-ad5c-e6a890569363
2617860154ANDARemedyrepack Inc.2015-03-02PREDNISOLONE SODIUM PHOSPHATE, SULFACETAMIDE SODIUMOPHTHALMICSOLUTION/DROPS242080317ANDA07444970a2bc8a-4918-420c-b9cb-0a35cc439f66

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073630SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEALCON PHARMACEUTICALS LTD1993-05-27ANDA073630_001
2ANDA074449SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATEBAUSCH AND LOMB PHARMACEUTICALS INC1995-12-29ANDA074449_001
3ANDA074511SULSTERTrueAKORN INC1996-07-30ANDA074511_001
4NDA018988VASOCIDINTrueNOVARTIS PHARMACEUTICALS CORP1988-08-26NDA018988_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073630_001RXPREDNISOLONE SODIUM PHOSPHATE (EQ 0.23% PHOSPHATE), SULFACETAMIDE SODIUM (10%)OPHTHALMICSOLUTION/DROPSFalseAT1993-05-27SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
2ANDA074449_001RXPREDNISOLONE SODIUM PHOSPHATE (EQ 0.23% PHOSPHATE), SULFACETAMIDE SODIUM (10%)OPHTHALMICSOLUTION/DROPSTrueAT1995-12-29SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
3ANDA074511_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.23% PHOSPHATE), SULFACETAMIDE SODIUM (10%)OPHTHALMICSOLUTION/DROPSFalse1996-07-30SULSTER
4NDA018988_001discontinuedPREDNISOLONE SODIUM PHOSPHATE (EQ 0.23% PHOSPHATE), SULFACETAMIDE SODIUM (10%)OPHTHALMICSOLUTION/DROPSFalse1988-08-26VASOCIDIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
170a2bc8a-4918-420c-b9cb-0a35cc439f66 (view SPL)Sulfacetamide Sodium and Prednisolone Sodium PhosphateOphthalmic Solution 10%/0.23%(prednisolone phosphate) (Sterile)prescriptionHuman PrescriptionRemedyrepack Inc.2015-03-021617860154
29ec403eb-b5df-4e41-9e17-9d9d8ecac3f3 (view SPL)Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution 10%/0.23% (prednisolone phosphate) (Sterile)prescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2014-02-104242080317
3ad1f288e-b2cc-4933-b12a-b034faa84fe4 (view SPL)Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic SolutionprescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-08-082613140297
4e5a2f3a5-2b9d-4d02-ad5c-e6a890569363 (view SPL)Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic SolutionprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-261216950186

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