Kytril

   
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Kytril


Drug - Kytril
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) - Granisetron Hydrochloride
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 020305
The FDA assigned number to Kytril. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Kytril. 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 - Mar 16, 1995
The date Kytril 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 Kytril. 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 Kytril is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Kytril.

Kytril