Amicar

   
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Amicar


Drug - Amicar
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) - Aminocaproic Acid
Multiple ingredients are in alphabetical order.

Strength - 500MG
The potency of the active ingredient(s), Aminocaproic Acid. May repeat for multiple part products.

Applicant - XANODYNE PHARM
The firm name holding legal responsibility for Amicar. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 015197
The FDA assigned number to Amicar. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Amicar. 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 Amicar 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 Amicar. 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 Amicar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Xanodyne Pharmacal Inc
The full name of the firm holding legal responsibility for the new application of Amicar.

Amicar