Drixoral Plus

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Drixoral Plus

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

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetaminophen; Dexbrompheniramine Maleate; Pseudoephedrine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 500MG;3MG;60MG
The potency of the active ingredient(s), Acetaminophen; Dexbrompheniramine Maleate; Pseudoephedrine Sulfate. May repeat for multiple part products.

The firm name holding legal responsibility for Drixoral Plus. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019453
The FDA assigned number to Drixoral Plus. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Drixoral Plus. 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 - May 22, 1987
The date Drixoral Plus 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 Drixoral Plus. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

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

Applicant Full Name - Schering Plough Healthcare Products Inc
The full name of the firm holding legal responsibility for the new application of Drixoral Plus.

Drixoral Plus