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OrapredDrug - Orapred The trade name of the product as shown on the labeling.
Dosage -
SOLUTION; ORAL
Active Ingredient(s) -
Prednisolone Sodium Phosphate
Strength -
EQ 15MG BASE/5ML
Applicant -
ASCENT PEDS
New Drug Application (NDA) Number -
075117
Product Number -
001
Therapeutic Equivalence (TE) Code -
AA
Approval Date -
Dec 14, 2000
Reference Listed Drug (RLD) -
Yes
Type -
RX
Applicant Full Name -
Ascent Pediatrics Inc
Orapred
Prednisolone Sodium Phosphate Eq 0.9% Phosphate Solution/drops; Ophthalmic
Prednisolone Sodium Phosphate Eq 0.9% Phosphate Solution/drops; Ophthalmic Prednisolone Sodium Phosphate Eq 0.9% Phosphate Solution/drops; Ophthalmic Orapred Eq 15mg Base/5ml Solution; Oral Prednisolone Sodium Phosphate Eq 0.9% Phosphate Solution/drops; Ophthalmic Prednisolone Sodium Phosphate Eq 0.11% Phosphate Solution/drops; Ophthalmic Prednisolone Sodium Phosphate Eq 0.9% Phosphate Solution/drops; Ophthalmic Prednisolone Sodium Phosphate Eq 0.11% Phosphate Solution/drops; Ophthalmic Prednisolone Sodium Phosphate Eq 0.9% Phosphate Solution/drops; Ophthalmic Prednisolone Sodium Phosphate Eq 0.11% Phosphate Solution/drops; Ophthalmic NewDrugInformation |