Zofran In Plastic Container

   
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Zofran In Plastic Container


Drug - Zofran In Plastic Container
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 0.64MG BASE/ML
The potency of the active ingredient(s), Ondansetron Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020403
The FDA assigned number to Zofran In Plastic Container. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Zofran In Plastic Container. 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 31, 1995
The date Zofran In Plastic Container 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 Zofran In Plastic Container. 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 In Plastic Container 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 In Plastic Container.

Zofran In Plastic Container