Cardizem Cd


Cardizem Cd

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

The product dosage form and route separated by a semi-colon.

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

Strength - 240MG
The potency of the active ingredient(s), Diltiazem Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020062
The FDA assigned number to Cardizem Cd. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Cardizem Cd. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB3
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 27, 1991
The date Cardizem Cd 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 Cardizem Cd. 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 Cardizem Cd is in. Format is RX, OTC, DISCN.

Applicant Full Name - Biovail Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Cardizem Cd.

Cardizem Cd