Argatroban

   
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Argatroban


Drug - Argatroban
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) - Argatroban
Multiple ingredients are in alphabetical order.

Strength - 100MG/ML
The potency of the active ingredient(s), Argatroban. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020883
The FDA assigned number to Argatroban. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Argatroban. 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 - Jun 30, 2000
The date Argatroban 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 Argatroban. 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 Argatroban is in. Format is RX, OTC, DISCN.

Applicant Full Name - Encysive Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Argatroban.

Argatroban