Myphetane Dx

   
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Myphetane Dx


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

New Drug Application (NDA) Number - 088811
The FDA assigned number to Myphetane Dx. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Myphetane Dx. 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 - Jun 7, 1985
The date Myphetane Dx 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) - Yes
The pioneer or innovator of Myphetane Dx. 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 Myphetane Dx 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 Myphetane Dx.

Myphetane Dx