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Predisolone Sodium Phosphate Drug - Predisolone Sodium Phosphate The trade name of the product as shown on the labeling. Dosage - SOLUTION; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Prednisolone Sodium Phosphate Multiple ingredients are in alphabetical order. Strength - EQ 15MG BASE/5ML The potency of the active ingredient(s), Prednisolone Sodium Phosphate. May repeat for multiple part products. Applicant - MORTON GROVE The firm name holding legal responsibility for Predisolone Sodium Phosphate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 076895 The FDA assigned number to Predisolone Sodium Phosphate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Predisolone Sodium Phosphate. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AA The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Oct 4, 2004 The date Predisolone Sodium Phosphate was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982". Reference Listed Drug (RLD) - No The pioneer or innovator of Predisolone Sodium Phosphate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - RX The group or category of approved drugs Predisolone Sodium Phosphate is in. Format is RX, OTC, DISCN. Applicant Full Name - Morton Grove Pharmaceuticals Inc The full name of the firm holding legal responsibility for the new application of Predisolone Sodium Phosphate. Predisolone Sodium Phosphate 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 Pediapred Eq 5mg Base/5ml Solution; Oral Predisolone Sodium Phosphate 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 NewDrugInformation