Mybanil

   
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Mybanil


Drug - Mybanil
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) - Bromodiphenhydramine Hydrochloride; Codeine Phosphate
Multiple ingredients are in alphabetical order.

Strength - 12.5MG/5ML;10MG/5ML
The potency of the active ingredient(s), Bromodiphenhydramine Hydrochloride; Codeine Phosphate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 088626
The FDA assigned number to Mybanil. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mybanil. 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 - Oct 12, 1984
The date Mybanil 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 Mybanil. 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 Mybanil 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 Mybanil.

Mybanil