Trinalin

   
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Trinalin


Drug - Trinalin
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) - Azatadine Maleate; Pseudoephedrine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 1MG;120MG
The potency of the active ingredient(s), Azatadine Maleate; Pseudoephedrine Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018506
The FDA assigned number to Trinalin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Trinalin. 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 - Mar 23, 1982
The date Trinalin 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 Trinalin. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Trinalin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Corp Sub Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of Trinalin.

Trinalin