Cefazolin Sodium

   
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Cefazolin Sodium


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

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

Applicant - HIKMA FARMACEUTICA
The firm name holding legal responsibility for Cefazolin Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065047
The FDA assigned number to Cefazolin Sodium. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Cefazolin Sodium. 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 - Sep 18, 2001
The date Cefazolin 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 Cefazolin Sodium. 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 Cefazolin Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hikma Farmaceutica Portugal Lda
The full name of the firm holding legal responsibility for the new application of Cefazolin Sodium.

Cefazolin Sodium