Cefotan

   
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Cefotan


Drug - Cefotan
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) - Cefotetan Disodium
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 063293
The FDA assigned number to Cefotan. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Cefotan. 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 - Apr 29, 1993
The date Cefotan 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 Cefotan. 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 Cefotan is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Pharmaceuticals Lp
The full name of the firm holding legal responsibility for the new application of Cefotan.

Cefotan