Dexchlorpheniramine Maleate

   
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Dexchlorpheniramine Maleate


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

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

Active Ingredient(s) - Dexchlorpheniramine Maleate
Multiple ingredients are in alphabetical order.

Strength - 2MG
The potency of the active ingredient(s), Dexchlorpheniramine Maleate. May repeat for multiple part products.

Applicant - PLIVA
The firm name holding legal responsibility for Dexchlorpheniramine Maleate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088682
The FDA assigned number to Dexchlorpheniramine Maleate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Dexchlorpheniramine Maleate. 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 - Jan 17, 1986
The date Dexchlorpheniramine Maleate 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 Dexchlorpheniramine Maleate. 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 Dexchlorpheniramine Maleate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pliva Inc
The full name of the firm holding legal responsibility for the new application of Dexchlorpheniramine Maleate.

Dexchlorpheniramine Maleate