Kytril

   
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Kytril


Drug - Kytril
The trade name of the product as shown on the labeling.

Dosage - SOLUTION; 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 2MG BASE/10ML
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 - 021238
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 - Jun 27, 2001
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


Neomycin Sulfate And Polymyxin B Sulfate Gramicidin 0.025mg/ml;eq 1.75mg Base/ml;10,000 Units/ml Solution/drops; Ophthalmic
Neo-polycin 0.025mg/ml;eq 1.75mg Base/ml;10,000 Units/ml Solution/drops; Ophthalmic
Neosporin 0.025mg/ml;eq 1.75mg Base/ml;10,000 Units/ml Solution/drops; Ophthalmic
Kytril Eq 0.1mg Base/ml (eq 0.1mg Base/ml) Injectable; Injection
Kytril Eq 1mg Base/ml (eq 1mg Base/ml) Injectable; Injection
Kytril Eq 3mg Base/ml Injectable; Injection
Kytril Eq 4mg Base/4ml (eq 1mg Base /ml) Injectable; Injection
Kytril Eq 2mg Base/10ml Solution; Oral
Neomycin And Polymyxin B Sulfates And Gramicidin 0.025mg/ml;eq 1.75mg Base/ml;10,000 Units/ml Solution/drops; Ophthalmic
Neomycin And Polymyxin B Sulfates And Gramicidin 0.025mg/ml;eq 1.75mg Base/ml;10,000 Units/ml Solution/drops; Ophthalmic

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