Zefazone

   
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Zefazone


Drug - Zefazone
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) - Cefmetazole Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM BASE/VIAL
The potency of the active ingredient(s), Cefmetazole Sodium. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for Zefazone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050637
The FDA assigned number to Zefazone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zefazone. 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 11, 1989
The date Zefazone 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 Zefazone. 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 Zefazone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn Co
The full name of the firm holding legal responsibility for the new application of Zefazone.

Zefazone