Penntuss

   
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Penntuss


Drug - Penntuss
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; Codeine Polistirex
Multiple ingredients are in alphabetical order.

Strength - EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML
The potency of the active ingredient(s), Chlorpheniramine Polistirex; Codeine Polistirex. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 018928
The FDA assigned number to Penntuss. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Penntuss. 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 - Aug 14, 1985
The date Penntuss 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 Penntuss. 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 Penntuss is in. Format is RX, OTC, DISCN.

Applicant Full Name - Fisons Corp
The full name of the firm holding legal responsibility for the new application of Penntuss.

Penntuss