Prograf

   
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Prograf


Drug - Prograf
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) - Tacrolimus
Multiple ingredients are in alphabetical order.

Strength - EQ 0.5MG BASE
The potency of the active ingredient(s), Tacrolimus. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050708
The FDA assigned number to Prograf. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Prograf. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Aug 24, 1998
The date Prograf 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 Prograf. 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 Prograf is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astellas Pharma Us Inc
The full name of the firm holding legal responsibility for the new application of Prograf.

Prograf