Sulphrin

   
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Sulphrin


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

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

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

Strength - 0.5%;10%
The potency of the active ingredient(s), Prednisolone Acetate; Sulfacetamide Sodium. May repeat for multiple part products.

Applicant - BAUSCH AND LOMB
The firm name holding legal responsibility for Sulphrin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088089
The FDA assigned number to Sulphrin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Sulphrin. 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 - Dec 28, 1982
The date Sulphrin 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 Sulphrin. 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 Sulphrin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bausch And Lomb Inc
The full name of the firm holding legal responsibility for the new application of Sulphrin.

Sulphrin