Trasicor

   
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Trasicor


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

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

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

Strength - 160MG
The potency of the active ingredient(s), Oxprenolol Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018166
The FDA assigned number to Trasicor. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Trasicor. 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 - Dec 28, 1983
The date Trasicor 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 Trasicor. 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 Trasicor is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Trasicor.

Trasicor