Agrylin

   
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Agrylin


Drug - Agrylin
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) - Anagrelide Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 1MG BASE
The potency of the active ingredient(s), Anagrelide Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020333
The FDA assigned number to Agrylin. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Agrylin. 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 - Mar 14, 1997
The date Agrylin 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 Agrylin. 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 Agrylin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Shire Development Inc
The full name of the firm holding legal responsibility for the new application of Agrylin.

Agrylin