Amaryl

   
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Amaryl


Drug - Amaryl
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) - Glimepiride
Multiple ingredients are in alphabetical order.

Strength - 2MG
The potency of the active ingredient(s), Glimepiride. May repeat for multiple part products.

Applicant - AVENTIS PHARMS
The firm name holding legal responsibility for Amaryl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020496
The FDA assigned number to Amaryl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Amaryl. 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 - Nov 30, 1995
The date Amaryl 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 Amaryl. 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 Amaryl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Amaryl.

Amaryl