Ifosfamide

   
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Ifosfamide


Drug - Ifosfamide
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) - Ifosfamide
Multiple ingredients are in alphabetical order.

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

Applicant - AM PHARM PARTNERS
The firm name holding legal responsibility for Ifosfamide. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076078
The FDA assigned number to Ifosfamide. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ifosfamide. 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 - May 28, 2002
The date Ifosfamide 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 Ifosfamide. 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 Ifosfamide is in. Format is RX, OTC, DISCN.

Applicant Full Name - American Pharmaceutical Partners Inc
The full name of the firm holding legal responsibility for the new application of Ifosfamide.

Ifosfamide