Cardizem La

   
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Cardizem La


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

Dosage - TABLET, 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 - 360MG
The potency of the active ingredient(s), Diltiazem Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021392
The FDA assigned number to Cardizem La. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Cardizem La. 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 - Feb 6, 2003
The date Cardizem La 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 La. 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 La 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 Cardizem La.

Cardizem La