Promethazine W/ Dextromethorphan

   
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Promethazine W/ Dextromethorphan


Drug - Promethazine W/ Dextromethorphan
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) - Dextromethorphan Hydrobromide; Promethazine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 15MG/5ML;6.25MG/5ML
The potency of the active ingredient(s), Dextromethorphan Hydrobromide; Promethazine Hydrochloride. May repeat for multiple part products.

Applicant - MORTON GROVE
The firm name holding legal responsibility for Promethazine W/ Dextromethorphan. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088864
The FDA assigned number to Promethazine W/ Dextromethorphan. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Promethazine W/ Dextromethorphan. 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 - Jan 4, 1985
The date Promethazine W/ Dextromethorphan 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 Promethazine W/ Dextromethorphan. 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 Promethazine W/ Dextromethorphan is in. Format is RX, OTC, DISCN.

Applicant Full Name - Morton Grove Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Promethazine W/ Dextromethorphan.

Promethazine W/ Dextromethorphan