Chlorpheniramine Maleate

   
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Chlorpheniramine Maleate


Drug - Chlorpheniramine 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) - Chlorpheniramine Maleate
Multiple ingredients are in alphabetical order.

Strength - 4MG
The potency of the active ingredient(s), Chlorpheniramine Maleate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 080938
The FDA assigned number to Chlorpheniramine Maleate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Chlorpheniramine 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 - Approved Prior to Jan 1, 1982
The date Chlorpheniramine 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) - No
The pioneer or innovator of Chlorpheniramine Maleate. 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 Chlorpheniramine Maleate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Elkins Sinn Div Ah Robins Co Inc
The full name of the firm holding legal responsibility for the new application of Chlorpheniramine Maleate.

Chlorpheniramine Maleate