Doxorubicin Hcl

   
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Doxorubicin Hcl


Drug - Doxorubicin Hcl
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) - Doxorubicin Hydrochloride
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 062921
The FDA assigned number to Doxorubicin Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Doxorubicin Hcl. 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 - Mar 17, 1989
The date Doxorubicin 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) - No
The pioneer or innovator of Doxorubicin 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 Doxorubicin Hcl 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 Doxorubicin Hcl.

Doxorubicin Hcl