Sectral

   
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Sectral


Drug - Sectral
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) - Acebutolol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 400MG BASE
The potency of the active ingredient(s), Acebutolol Hydrochloride. May repeat for multiple part products.

Applicant - ESP PHARMA
The firm name holding legal responsibility for Sectral. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018917
The FDA assigned number to Sectral. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Sectral. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Dec 28, 1984
The date Sectral 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) - Yes
The pioneer or innovator of Sectral. 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 Sectral is in. Format is RX, OTC, DISCN.

Applicant Full Name - Esp Pharma Inc
The full name of the firm holding legal responsibility for the new application of Sectral.

Sectral