Aggrastat

   
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Aggrastat


Drug - Aggrastat
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) - Tirofiban Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 0.05MG BASE/ML
The potency of the active ingredient(s), Tirofiban Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020913
The FDA assigned number to Aggrastat. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Aggrastat. 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 - May 14, 1998
The date Aggrastat 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 Aggrastat. 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 Aggrastat is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mgi Pharma Inc
The full name of the firm holding legal responsibility for the new application of Aggrastat.

Aggrastat