Cerubidine

   
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Cerubidine


Drug - Cerubidine
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) - Daunorubicin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 20MG BASE/VIAL
The potency of the active ingredient(s), Daunorubicin Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 064103
The FDA assigned number to Cerubidine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cerubidine. 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 - Feb 3, 1995
The date Cerubidine 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 Cerubidine. 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 Cerubidine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bedford Laboratories Div Ben Venue Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Cerubidine.

Cerubidine