Sulster

   
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Sulster


Drug - Sulster
The trade name of the product as shown on the labeling.

Dosage - SOLUTION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Prednisolone Sodium Phosphate; Sulfacetamide Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 0.23% PHOSPHATE;10%
The potency of the active ingredient(s), Prednisolone Sodium Phosphate; Sulfacetamide Sodium. May repeat for multiple part products.

Applicant - AKORN
The firm name holding legal responsibility for Sulster. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074511
The FDA assigned number to Sulster. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Sulster. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jul 30, 1996
The date Sulster 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 Sulster. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Sulster is in. Format is RX, OTC, DISCN.

Applicant Full Name - Akorn Inc
The full name of the firm holding legal responsibility for the new application of Sulster.

Sulster