Mandol

   
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Mandol


Drug - Mandol
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) - Cefamandole Nafate
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 050504
The FDA assigned number to Mandol. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Mandol. 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 - Approved Prior to Jan 1, 1982
The date Mandol 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 Mandol. 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 Mandol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Eli Lilly And Co
The full name of the firm holding legal responsibility for the new application of Mandol.

Mandol