Phenytoin Sodium

   
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Phenytoin Sodium


Drug - Phenytoin Sodium
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) - Phenytoin Sodium
Multiple ingredients are in alphabetical order.

Strength - 50MG/ML
The potency of the active ingredient(s), Phenytoin Sodium. May repeat for multiple part products.

Applicant - SMITH AND NEPHEW
The firm name holding legal responsibility for Phenytoin Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088521
The FDA assigned number to Phenytoin Sodium. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Phenytoin Sodium. 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 18, 1984
The date Phenytoin Sodium 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 Phenytoin Sodium. 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 Phenytoin Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Smith And Nephew Solopak Div Smith And Nephew
The full name of the firm holding legal responsibility for the new application of Phenytoin Sodium.

Phenytoin Sodium