Quadramet

   
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Quadramet


Drug - Quadramet
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) - Samarium Sm 153 Lexidronam Pentasodium
Multiple ingredients are in alphabetical order.

Strength - 50mCi/ML
The potency of the active ingredient(s), Samarium Sm 153 Lexidronam Pentasodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020570
The FDA assigned number to Quadramet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Quadramet. 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 - Mar 28, 1997
The date Quadramet 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) - Yes
The pioneer or innovator of Quadramet. 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 Quadramet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Cytogen Corp
The full name of the firm holding legal responsibility for the new application of Quadramet.

Quadramet