prednisolone Ophthalmic Suspension

Brand(s)
Omnipred, Pred Forte, Pred Mild
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2014-04-30)
Oldest Current Product
1972-12-01
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
OPHTHALMIC SUSPENSION\PREDNISOLONE
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\PREDNISOLONE ACETATE
SPL Active
OPHTHALMIC\SUSPENSION/DROPS\PREDNISOLONE ACETATE
OPHTHALMIC\SUSPENSION\PREDNISOLONE ACETATE
SPL Moiety
OPHTHALMIC\SUSPENSION/DROPS\PREDNISOLONE
OPHTHALMIC\SUSPENSION\PREDNISOLONE

product(s) by strength(s)

prednisolone 1.2 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1119800174Pred MildNDAAllergan, Inc.1972-12-01PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPSNDA0171004fcce64a-94ea-4031-ad5a-c4eddc73a910

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686355Pred MildNDAPhysicians Total Care, Inc.2012-11-01PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS119800174NDA0171004c1ec8d2-9128-402e-a723-87dc7b444655
2687889876Pred MildNDAPreferred Pharmaceuticals, Inc.2012-03-05PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS119800174NDA01710090fba723-51b1-4404-a30b-816f35001d91

prednisolone acetate 10 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1119800180Pred ForteNDAAllergan, Inc.1973-06-01PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPSNDA01701100a5aa88-e361-4ea7-8922-530c738b726e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607580119NDA AUTHORIZED GENERICPacific Pharma, Inc.1997-08-19PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPSNDA0170111474d1df-70b6-4b1e-86d1-3349aa6d42fb
2613140637NDA AUTHORIZED GENERICSandoz Inc1994-12-15PREDNISOLONE ACETATEOPHTHALMICSUSPENSIONNDA01746905d205c7-8f51-46b9-a6c5-4199bc432b26

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250484NDA AUTHORIZED GENERICRemedyrepack Inc.2013-04-12PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS607580119NDA017011b7d8267f-691f-4e18-b0dd-13b5c12ea016
2529590265NDA AUTHORIZED GENERICH.J. Harkins Company, Inc.1997-08-19PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS607580119NDA017011c77597c4-8add-4d2a-b8c1-e526cbe22dcb
3545690871Pred ForteNDAA-S Medication Solutions Llc1973-06-01PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS119800180NDA017011c6423e38-edb4-48e0-bf89-d5199ad4b7a1
4545692868Pred ForteNDAA-S Medication Solutions Llc1973-06-01PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS119800180NDA017011d3139d6e-eb13-4e1f-8a3f-5fe480465601
5548684293NDA AUTHORIZED GENERICPhysicians Total Care, Inc.2002-11-04PREDNISOLONE ACETATEOPHTHALMICSUSPENSION613140637NDA017469b17d2a0e-5f89-4253-9a8a-bb6ec59919fe
6581189839NDA AUTHORIZED GENERICClinical Solutions Wholesale1994-12-15PREDNISOLONE ACETATEOPHTHALMICSUSPENSION613140637NDA017469616824aa-5865-4d68-9e3a-9ff8aa4fb05e
7687889733NDA AUTHORIZED GENERICPreferred Pharmaceuticals, Inc.2012-10-23PREDNISOLONE ACETATEOPHTHALMICSUSPENSION/DROPS607580119NDA0170114bf2d51d-2944-4450-a817-1baec6a909ef

application(s)

#idtitledeprecatedapplicantapproved drug
1NDA017011PRED FORTEALLERGAN PHARMACEUTICALNDA017011_001
2NDA017100PRED MILDALLERGAN PHARMACEUTICALNDA017100_001
3NDA017468ECONOPREDTrueALCON LABORATORIES INCNDA017468_001
4NDA017469OMNIPREDALCON LABORATORIES INCNDA017469_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapplication
1NDA017011_001RXPREDNISOLONE ACETATE (1%)OPHTHALMICSUSPENSION/DROPSTrueABPRED FORTE
2NDA017100_001RXPREDNISOLONE ACETATE (0.12%)OPHTHALMICSUSPENSION/DROPSTruePRED MILD
3NDA017468_001discontinuedPREDNISOLONE ACETATE (0.125%)OPHTHALMICSUSPENSION/DROPSFalseECONOPRED
4NDA017469_001RXPREDNISOLONE ACETATE (1%)OPHTHALMICSUSPENSION/DROPSFalseABOMNIPRED

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100a5aa88-e361-4ea7-8922-530c738b726e (view SPL)PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1%sterileprescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2013-08-316119800180
205d205c7-8f51-46b9-a6c5-4199bc432b26 (view SPL)Prednisolone Acetate Ophthalmic Suspension USP, 1%prescriptionHuman PrescriptionSandoz IncMANUFACTURE2011-07-202613140637
31474d1df-70b6-4b1e-86d1-3349aa6d42fb (view SPL)PREDNISOLONE ACETATEophthalmic suspension, USP 1%prescriptionHuman PrescriptionPacific Pharma, Inc.MANUFACTURE2014-03-263607580119
44bbb4356-b4b3-4497-a3a3-8f4b65d326fe (view SPL)OMNIPRED (prednisolone acetate ophthalmic suspension)prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-07-282000650638
54bf2d51d-2944-4450-a817-1baec6a909ef (view SPL)PREDNISOLONE ACETATEophthalmic suspension, USP 1.0%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-10-231687889733
64c1ec8d2-9128-402e-a723-87dc7b444655 (view SPL)PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-01-021548686355
74fcce64a-94ea-4031-ad5a-c4eddc73a910 (view SPL)PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12%sterileprescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2014-04-304119800174
8616824aa-5865-4d68-9e3a-9ff8aa4fb05e (view SPL)Prednisolone Acetate Ophthalmic Suspension USP, 1%prescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL2013-12-231581189839
990fba723-51b1-4404-a30b-816f35001d91 (view SPL)PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12%prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-03-051687889876
10b17d2a0e-5f89-4253-9a8a-bb6ec59919fe (view SPL)Prednisolone Acetate Ophthalmic Suspension USP, 1%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-10-232548684293
11b7d8267f-691f-4e18-b0dd-13b5c12ea016 (view SPL)PREDNISOLONE ACETATEophthalmic suspension, USP 1.0%prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-121521250484
12c6423e38-edb4-48e0-bf89-d5199ad4b7a1 (view SPL)PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545690871
13c77597c4-8add-4d2a-b8c1-e526cbe22dcb (view SPL)PREDNISOLONE ACETATEophthalmic suspension, USP 1.0%prescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2011-11-173529590265
14d3139d6e-eb13-4e1f-8a3f-5fe480465601 (view SPL)PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1%prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-06-291545692868

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