Promethacon

   
Google
 
Web NewDrugInformation.com

Promethacon


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

Dosage - SUPPOSITORY; RECTAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Promethazine Hydrochloride
Multiple ingredients are in alphabetical order.

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

Applicant - POLYMEDICA
The firm name holding legal responsibility for Promethacon. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 084901
The FDA assigned number to Promethacon. Format is nnnnnn.

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

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

Approval Date - Approved Prior to Jan 1, 1982
The date Promethacon 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 Promethacon. 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 Promethacon is in. Format is RX, OTC, DISCN.

Applicant Full Name - Polymedica Industries Inc
The full name of the firm holding legal responsibility for the new application of Promethacon.

Promethacon