Tiazac

   
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Tiazac


Drug - Tiazac
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 - 120MG
The potency of the active ingredient(s), Diltiazem Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020401
The FDA assigned number to Tiazac. Format is nnnnnn.

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

Therapeutic Equivalence (TE) Code - AB4
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 11, 1995
The date Tiazac 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 Tiazac. 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 Tiazac is in. Format is RX, OTC, DISCN.

Applicant Full Name - Biovail Corp International
The full name of the firm holding legal responsibility for the new application of Tiazac.

Tiazac