Tussionex

   
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Tussionex


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

Dosage - SUSPENSION, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Chlorpheniramine Polistirex; Hydrocodone Polistirex
Multiple ingredients are in alphabetical order.

Strength - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
The potency of the active ingredient(s), Chlorpheniramine Polistirex; Hydrocodone Polistirex. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019111
The FDA assigned number to Tussionex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tussionex. 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 - Dec 31, 1987
The date Tussionex 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 Tussionex. 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 Tussionex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ucb Pharma Inc
The full name of the firm holding legal responsibility for the new application of Tussionex.

Tussionex