Imitrex

   
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Imitrex


Drug - Imitrex
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) - Sumatriptan Succinate
Multiple ingredients are in alphabetical order.

Strength - EQ 50MG BASE
The potency of the active ingredient(s), Sumatriptan Succinate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020132
The FDA assigned number to Imitrex. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Imitrex. 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 1, 1995
The date Imitrex 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 Imitrex. 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 Imitrex 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 Imitrex.

Imitrex