Lyophilized Cytoxan

   
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Lyophilized Cytoxan


Drug - Lyophilized Cytoxan
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) - Cyclophosphamide
Multiple ingredients are in alphabetical order.

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

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Lyophilized Cytoxan. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 012142
The FDA assigned number to Lyophilized Cytoxan. Format is nnnnnn.

Product Number - 010
The FDA assigned number to identify Lyophilized Cytoxan. 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 24, 1985
The date Lyophilized Cytoxan 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 Lyophilized Cytoxan. 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 Lyophilized Cytoxan is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Co Pharmaceutical Research Institute
The full name of the firm holding legal responsibility for the new application of Lyophilized Cytoxan.

Lyophilized Cytoxan