Definity

   
Google
 
Web NewDrugInformation.com

Definity


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

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

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

Strength - 6.52MG/ML
The potency of the active ingredient(s), Perflutren. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Definity. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021064
The FDA assigned number to Definity. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Definity. 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 - Jul 31, 2001
The date Definity 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 Definity. 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 Definity is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Medical Imaging
The full name of the firm holding legal responsibility for the new application of Definity.

Definity