Ifosfamide/mesna Kit

   
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Ifosfamide/mesna Kit


Drug - Ifosfamide/mesna Kit
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INTRAVENOUS
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ifosfamide; Mesna
Multiple ingredients are in alphabetical order.

Strength - EQ 1GM /20ML(50MG/ML);EQ 1GM /10ML(100MG/ML)
The potency of the active ingredient(s), Ifosfamide; Mesna. May repeat for multiple part products.

Applicant - SICOR PHARMS
The firm name holding legal responsibility for Ifosfamide/mesna Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075874
The FDA assigned number to Ifosfamide/mesna Kit. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ifosfamide/mesna Kit. 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 - Feb 26, 2002
The date Ifosfamide/mesna Kit 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/mesna Kit. 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/mesna Kit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sicor Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Ifosfamide/mesna Kit.

Ifosfamide/mesna Kit