Idarubicin Hcl


Idarubicin Hcl

Drug - Idarubicin Hcl
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Idarubicin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 10MG/VIAL
The potency of the active ingredient(s), Idarubicin Hydrochloride. May repeat for multiple part products.

Applicant - SICOR PHARMS
The firm name holding legal responsibility for Idarubicin Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065037
The FDA assigned number to Idarubicin Hcl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Idarubicin Hcl. 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 1, 2002
The date Idarubicin Hcl 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 Idarubicin Hcl. 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 Idarubicin Hcl 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 Idarubicin Hcl.

Idarubicin Hcl