Bromfed-dm

   
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Bromfed-dm


Drug - Bromfed-dm
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2MG/5ML;10MG/5ML;30MG/5ML
The potency of the active ingredient(s), Brompheniramine Maleate; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride. May repeat for multiple part products.

Applicant - BRIGHTON PHARMS INC
The firm name holding legal responsibility for Bromfed-dm. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089681
The FDA assigned number to Bromfed-dm. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Bromfed-dm. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 22, 1988
The date Bromfed-dm 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 Bromfed-dm. 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 Bromfed-dm is in. Format is RX, OTC, DISCN.

Applicant Full Name - Brighton Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Bromfed-dm.

Bromfed-dm