Cefuroxime

   
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Cefuroxime


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

Strength - EQ 7.5GM BASE/VIAL
The potency of the active ingredient(s), Cefuroxime Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 064191
The FDA assigned number to Cefuroxime. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cefuroxime. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Apr 16, 1998
The date Cefuroxime 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 Cefuroxime. 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 Cefuroxime is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Cefuroxime.

Cefuroxime