Cardizem Sr

   
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Cardizem Sr


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

Dosage - CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 180MG
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 Sr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019471
The FDA assigned number to Cardizem Sr. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Cardizem Sr. 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 - Jan 23, 1989
The date Cardizem Sr 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 Sr. 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 Cardizem Sr 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 Sr.

Cardizem Sr