Ellence

   
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Ellence


Drug - Ellence
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) - Epirubicin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2MG/ML
The potency of the active ingredient(s), Epirubicin Hydrochloride. May repeat for multiple part products.

Applicant - PFIZER INC
The firm name holding legal responsibility for Ellence. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050778
The FDA assigned number to Ellence. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ellence. 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 - Sep 15, 1999
The date Ellence 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 Ellence. 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 Ellence is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Inc
The full name of the firm holding legal responsibility for the new application of Ellence.

Ellence