Dimetane

   
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Dimetane


Drug - Dimetane
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) - Brompheniramine Maleate
Multiple ingredients are in alphabetical order.

Strength - 8MG
The potency of the active ingredient(s), Brompheniramine Maleate. May repeat for multiple part products.

Applicant - WYETH CONS
The firm name holding legal responsibility for Dimetane. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 010799
The FDA assigned number to Dimetane. Format is nnnnnn.

Product Number - 010
The FDA assigned number to identify Dimetane. 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 - Jun 10, 1983
The date Dimetane 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 Dimetane. 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 Dimetane is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Consumer Healthcare
The full name of the firm holding legal responsibility for the new application of Dimetane.

Dimetane