Copaxone

   
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Copaxone


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

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

Active Ingredient(s) - Glatiramer Acetate
Multiple ingredients are in alphabetical order.

Strength - 20MG/ML
The potency of the active ingredient(s), Glatiramer Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020622
The FDA assigned number to Copaxone. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Copaxone. 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 12, 2002
The date Copaxone 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 Copaxone. 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 Copaxone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Neuroscience Inc
The full name of the firm holding legal responsibility for the new application of Copaxone.

Copaxone