Cerebyx

   
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Cerebyx


Drug - Cerebyx
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) - Fosphenytoin Sodium
Multiple ingredients are in alphabetical order.

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

Applicant - PARKE DAVIS
The firm name holding legal responsibility for Cerebyx. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020450
The FDA assigned number to Cerebyx. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cerebyx. 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 - Aug 5, 1996
The date Cerebyx 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) - Yes
The pioneer or innovator of Cerebyx. 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 Cerebyx is in. Format is RX, OTC, DISCN.

Applicant Full Name - Parke Davis Div Warner Lambert Co
The full name of the firm holding legal responsibility for the new application of Cerebyx.

Cerebyx