Mymethazine Fortis

   
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Mymethazine Fortis


Drug - Mymethazine Fortis
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) - Promethazine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 25MG/5ML
The potency of the active ingredient(s), Promethazine Hydrochloride. May repeat for multiple part products.

Applicant - USL PHARMA
The firm name holding legal responsibility for Mymethazine Fortis. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087996
The FDA assigned number to Mymethazine Fortis. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mymethazine Fortis. 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 - Jan 18, 1983
The date Mymethazine Fortis 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 Mymethazine Fortis. 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 Mymethazine Fortis is in. Format is RX, OTC, DISCN.

Applicant Full Name - Usl Pharma Inc
The full name of the firm holding legal responsibility for the new application of Mymethazine Fortis.

Mymethazine Fortis