Sorbitrate

   
Google
 
Web NewDrugInformation.com

Sorbitrate


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

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

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

Strength - 2.5MG
The potency of the active ingredient(s), Isosorbide Dinitrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 016191
The FDA assigned number to Sorbitrate. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Sorbitrate. 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 - Apr 1, 1996
The date Sorbitrate 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 Sorbitrate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Sorbitrate 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 Sorbitrate.

Sorbitrate