Wytensin

   
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Wytensin


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

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

Active Ingredient(s) - Guanabenz Acetate
Multiple ingredients are in alphabetical order.

Strength - EQ 16MG BASE
The potency of the active ingredient(s), Guanabenz Acetate. May repeat for multiple part products.

Applicant - WYETH AYERST
The firm name holding legal responsibility for Wytensin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018587
The FDA assigned number to Wytensin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Wytensin. 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 - Sep 7, 1982
The date Wytensin 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 Wytensin. 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 Wytensin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Ayerst Laboratories
The full name of the firm holding legal responsibility for the new application of Wytensin.

Wytensin