Crestor

   
Google
 
Web NewDrugInformation.com

Crestor


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 5MG
The potency of the active ingredient(s), Rosuvastatin Calcium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021366
The FDA assigned number to Crestor. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Crestor. 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 - Aug 12, 2003
The date Crestor 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) - No
The pioneer or innovator of Crestor. 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 Crestor is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Pharmaceuticals Lp
The full name of the firm holding legal responsibility for the new application of Crestor.

Crestor