Surital

   
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Surital


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Thiamylal Sodium
Multiple ingredients are in alphabetical order.

Strength - 10GM/VIAL
The potency of the active ingredient(s), Thiamylal Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 007600
The FDA assigned number to Surital. Format is nnnnnn.

Product Number - 009
The FDA assigned number to identify Surital. 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 - Approved Prior to Jan 1, 1982
The date Surital 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 Surital. 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 Surital is in. Format is RX, OTC, DISCN.

Applicant Full Name - Parkedale Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Surital.

Surital