Allegra-d 12 Hour

   
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Allegra-d 12 Hour


Drug - Allegra-d 12 Hour
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 60MG;120MG
The potency of the active ingredient(s), Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride. May repeat for multiple part products.

Applicant - AVENTIS PHARMS
The firm name holding legal responsibility for Allegra-d 12 Hour. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020786
The FDA assigned number to Allegra-d 12 Hour. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Allegra-d 12 Hour. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 24, 1997
The date Allegra-d 12 Hour 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 Allegra-d 12 Hour. 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 Allegra-d 12 Hour is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Allegra-d 12 Hour.

Allegra-d 12 Hour