Zofran Odt

   
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Zofran Odt


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

Dosage - TABLET, ORALLY DISINTEGRATING; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ondansetron
Multiple ingredients are in alphabetical order.

Strength - EQ 4MG BASE
The potency of the active ingredient(s), Ondansetron. May repeat for multiple part products.

Applicant - GLAXOSMITHKLINE
The firm name holding legal responsibility for Zofran Odt. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020781
The FDA assigned number to Zofran Odt. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zofran Odt. 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 - Jan 27, 1999
The date Zofran Odt 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 Zofran Odt. 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 Zofran Odt is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Zofran Odt.

Zofran Odt