Amoxil

   
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Amoxil


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

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

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

Strength - 50MG/ML
The potency of the active ingredient(s), Amoxicillin. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062226
The FDA assigned number to Amoxil. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Amoxil. 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 - Approved Prior to Jan 1, 1982
The date Amoxil 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 Amoxil. 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 Amoxil is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Amoxil.

Amoxil