Vasotec

   
Google
 
Web NewDrugInformation.com

Vasotec


Drug - Vasotec
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) - Enalapril Maleate
Multiple ingredients are in alphabetical order.

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

Applicant - BIOVAIL LABS INTL
The firm name holding legal responsibility for Vasotec. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018998
The FDA assigned number to Vasotec. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vasotec. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 24, 1985
The date Vasotec 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 Vasotec. 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 Vasotec is in. Format is RX, OTC, DISCN.

Applicant Full Name - Biovail Laboratories International Srl
The full name of the firm holding legal responsibility for the new application of Vasotec.

Vasotec