Acebutolol Hcl

   
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Acebutolol Hcl


Drug - Acebutolol Hcl
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 200MG BASE
The potency of the active ingredient(s), Acebutolol Hydrochloride. May repeat for multiple part products.

Applicant - MYLAN
The firm name holding legal responsibility for Acebutolol Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074288
The FDA assigned number to Acebutolol Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acebutolol Hcl. 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 - Apr 24, 1995
The date Acebutolol Hcl 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 Acebutolol Hcl. 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 Acebutolol Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mylan Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Acebutolol Hcl.

Acebutolol Hcl