Precef

   
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Precef


Drug - Precef
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) - Ceforanide
Multiple ingredients are in alphabetical order.

Strength - 2GM/VIAL
The potency of the active ingredient(s), Ceforanide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062579
The FDA assigned number to Precef. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Precef. 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 - Nov 26, 1984
The date Precef 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 Precef. 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 Precef is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Precef.

Precef