FDA Approval Activities for this Drug…

Econopred & Econopred Plus (prednisolone acetate ophthalmic suspension), 1/8% and 1% respectively, Alcon, NDA 17-468/S-019 & 17-469/S-031 Orapred (Prednisolone Sodium Phosphate) Solution, 15 mg (base)/5 mL, Ascent Pediatrics ANDA 75-117 Pediapred (prednisolone sodium phospahte, USP) Solution, Medeva NDA 19-157/S-016 1/21/98 9/11/03 Pediapred (prednisolone sodium phospahte, USP) Solution, Medeva NDA 19-157/S-011, S-012, S-013, S-015 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, Pharmaceutical Associates, ANDA 76-123 12/23/02 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, Pharmaceutical Associates, ANDA 76-123 5/13/02 Prednisolone Sodium Phosphate Solution, 15 mg (base)/5 mL, WE ANDA 75-250 7/12/02 Prednisolone Sodium Phosphate Solution, 15 mg (base)/5 mL, WE ANDA 75-250 1/4/02 4/9/03 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, Hi-Tech Pharmacal Co., ANDA 75-183 3/26/03 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, Hi-Tech Pharmacal Co., ANDA 75-183 10/17/02 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, WE ANDA 75-181 12/23/02 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, WE ANDA 75-181 2/13/02 4/9/03 Prednisolone Sodium Phosphate Solution, 5 mg (base)/5 mL, Morton Grove ANDA 75-099 6/28/02 10/28/02 Prednisolone Syrup USP, 5 mg/5 mL, KV Pharmaceutical Company ANDA 40-423 10/22/01 4/10/03 Prednisolone Syrup USP, 15 mg/5 mL, Hi-Tech Pharmacal Co., ANDA 40-401 2/27/03 Prednisolone Syrup USP, 15 mg/5 mL, Pharmaceutical Associates, ANDA 40-399 3/5/03 Prednisolone Syrup USP, 15 mg/5 mL, KV Pharmaceutical Company ANDA 40-364 4/10/02 4/8/03 Prednisolone Syrup USP, 15 mg/5 mL. UDL , ANDA 40-323 5/13/99 5/18/99 2/15/00 2/15/00 Prednisolone Syrup USP, 15 mg/5 mL Syrup, Copley Pharmaceutical, ANDA 40-322 1/19/00 1/24/00 1/24/02 Prednisolone Syrup USP, 15 mg/5 mL, Morton Grove ANDA 40-313 9/10/03 Prednisolone Syrup USP, 15 mg/5 mL. Halsey Drug Company, ANDA 40-287 5/28/99 6/1/99 8/4/03 Prednisolone Syrup USP, 15 mg/5 mL WE ANDA 40-192 Pred-G (gentamicin and prednisolone acetate) Ophthalmic Ointment, Allergan, GENTAMICIN SULFATE; PREDNISOLONE ACETATE Ointment; Ophthalmic 0.3% BASE;0.6% PRED-G ALLERGAN 050586 GENTAMICIN SULFATE; PREDNISOLONE ACETATE Suspension/Drops; Ophthalmic 0.3% BASE;1% PRED-G ALLERGAN 088497 METHYLPREDNISOLONE Tablet; 4MG METHYLPREDNISOLONE DURAMED Barr 040194 METHYLPREDNISOLONE Tablet; 4MG METHYLPREDNISOLONE Geneva 089207 METHYLPREDNISOLONE Tablet; 16MG METHYLPREDNISOLONE Par 089208 METHYLPREDNISOLONE Tablet; 24MG METHYLPREDNISOLONE Par 089209 METHYLPREDNISOLONE Tablet; 32MG METHYLPREDNISOLONE Par 011153 METHYLPREDNISOLONE Tablet; 16MG MEDROL PHARMACIA AND UPJOHN 011153 METHYLPREDNISOLONE Tablet; 24MG MEDROL PHARMACIA AND UPJOHN 011153 METHYLPREDNISOLONE Tablet; 32MG MEDROL PHARMACIA AND UPJOHN 011153 METHYLPREDNISOLONE Tablet; 4MG MEDROL PHARMACIA AND UPJOHN 011153 METHYLPREDNISOLONE Tablet; 8MG MEDROL PHARMACIA AND UPJOHN 040189 METHYLPREDNISOLONE Tablet; 4MG METHYLPREDNISOLONE TRIGEN 040189 METHYLPREDNISOLONE Tablet; 8MG METHYLPREDNISOLONE TRIGEN 040183 METHYLPREDNISOLONE Tablet; 4MG METHYLPREDNISOLONE Vintage 040232 METHYLPREDNISOLONE Tablet; 4MG METHYLPREDNISOLONE Watson 011757 BP METHYLPREDNISOLONE ACETATE Injection 20MG/ML DEPO-MEDROL PHARMACIA AND UPJOHN 011757 METHYLPREDNISOLONE ACETATE Injection 40MG/ML DEPO-MEDROL PHARMACIA AND UPJOHN 011757 METHYLPREDNISOLONE ACETATE Injection 80MG/ML DEPO-MEDROL PHARMACIA AND UPJOHN 085855 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 125MG BASE/VIAL A-METHAPRED Abbott 089174 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 1GM BASE/VIAL A-METHAPRED Abbott 085852 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 1GM BASE/VIAL A-METHAPRED Abbott 085853 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 40MG BASE/VIAL A-METHAPRED Abbott 085854 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 500MG BASE/VIAL A-METHAPRED Abbott 089173 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 500MG BASE/VIAL A-METHAPRED Abbott 081266 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 125MG BASE/VIAL METHYLPREDNISOLONE SODIUM SUCCINATE Gensia Sicor 011856 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 125MG BASE/VIAL SOLU-MEDROL PHARMACIA AND UPJOHN 011856 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 1GM BASE/VIAL SOLU-MEDROL PHARMACIA AND UPJOHN 011856 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 2GM BASE/VIAL SOLU-MEDROL PHARMACIA AND UPJOHN 011856 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 40MG BASE/VIAL SOLU-MEDROL PHARMACIA AND UPJOHN 011856 METHYLPREDNISOLONE SODIUM SUCCINATE Injection 500MG BASE/VIAL SOLU-MEDROL PHARMACIA AND UPJOHN 050081 NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE Suspension/Drops; Ophthalmic 0.35% BASE;10,000 UNITS/ML;0.5% POLY-PRED ALLERGAN 040287 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE AXIOM 040322 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE Copley 040401 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE HI TECH 040364 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE KV 040423 PREDNISOLONE Syrup; 5MG/5ML PREDNISOLONE KV 040313 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE Morton Grove 040399 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE ASSOC 089081 PREDNISOLONE Syrup; 15MG/5ML PRELONE Teva 040323 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE UDL 040192 PREDNISOLONE Syrup; 15MG/5ML PREDNISOLONE WE 084439 BX PREDNISOLONE Tablet; 2.5MG PREDNISOLONE EVERYLIFE 084439 BX PREDNISOLONE Tablet; 5MG PREDNISOLONE EVERYLIFE 080531 BX PREDNISOLONE Tablet; 5MG PREDNISOLONE LANNETT 080307 BX PREDNISOLONE Tablet; 5MG PREDNISOLONE MARSHALL 080358 PREDNISOLONE Tablet; 1MG PREDNISOLONE SPERTI 080358 BX PREDNISOLONE Tablet; 2.5MG PREDNISOLONE SPERTI 080358 BX PREDNISOLONE Tablet; 5MG PREDNISOLONE SPERTI 080354 BX PREDNISOLONE Tablet; 5MG PREDNISOLONE Watson 083398 PREDNISOLONE ACETATE Injection 25MG/ML PREDNISOLONE ACETATE STERIS 085781 PREDNISOLONE ACETATE Injection 50MG/ML PREDNISOLONE ACETATE STERIS 083764 PREDNISOLONE ACETATE Injection 50MG/ML PREDNISOLONE ACETATE STERIS 017100 PREDNISOLONE ACETATE Suspension/Drops; Ophthalmic 0.12% PRED MILD ALLERGAN 017011 PREDNISOLONE ACETATE Suspension/Drops; Ophthalmic 1% PRED FORTE ALLERGAN 017469 PREDNISOLONE ACETATE Suspension/Drops; Ophthalmic 1% ECONOPRED PLUS FALCON 087748 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM Ointment; Ophthalmic 0.2%;10% BLEPHAMIDE S.O.P. ALLERGAN 088791 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM Ointment; Ophthalmic 0.5%;10% VASOCIDIN NOVARTIS 012813 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM Suspension; Ophthalmic 0.2%;10% BLEPHAMIDE ALLERGAN 040065 AT PREDNISOLONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic 0.11% PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE BAUSCH AND LOMB 040070 AT PREDNISOLONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic 0.9% PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE BAUSCH AND LOMB 080751 AT PREDNISOLONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic 0.11% PHOSPHATE INFLAMASE MILD NOVARTIS 080751 AT PREDNISOLONE SODIUM PHOSPHATE Solution/Drops; Ophthalmic 0.9% PHOSPHATE INFLAMASE FORTE NOVARTIS 075117 PREDNISOLONE SODIUM PHOSPHATE Solution; 15MG BASE/5ML ORAPRED ASCENT PEDS 019157 PREDNISOLONE SODIUM PHOSPHATE Solution; 5MG BASE/5ML PEDIAPRED CELLTECH 075183 PREDNISOLONE SODIUM PHOSPHATE Solution; 5MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE HI TECH 075099 PREDNISOLONE SODIUM PHOSPHATE Solution; 5MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE Morton Grove 076123 PREDNISOLONE SODIUM PHOSPHATE Solution; 5MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE ASSOC 075250 PREDNISOLONE SODIUM PHOSPHATE Solution; 15MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE WE 075181 PREDNISOLONE SODIUM PHOSPHATE Solution; 5MG BASE/5ML PREDNISOLONE SODIUM PHOSPHATE WE 073630 AT PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 0.23% PHOSPHATE;10% SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE Alcon 074449 AT PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 0.23% PHOSPHATE;10% SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE BAUSCH AND LOMB 018988 AT PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Solution/Drops; Ophthalmic 0.23% PHOSPHATE;10% VASOCIDIN NOVARTIS | Prednisolone Sodium Phosphate Oral Solution, Morton Grove Pharma, Approval | Prediapred (prednisolone sodium phosphate) Oral Solution, Celltech Pharma, Labeling Revision | Prednisolone Acetate Suspension Injectable, Sicor Pharma, Approval | Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Associates, Approval

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