Prometh Plain

   
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Prometh Plain


Drug - Prometh Plain
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 - 6.25MG/5ML
The potency of the active ingredient(s), Promethazine Hydrochloride. May repeat for multiple part products.

Applicant - ALPHARMA US PHARMS
The firm name holding legal responsibility for Prometh Plain. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085953
The FDA assigned number to Prometh Plain. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Prometh Plain. 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 - Approved Prior to Jan 1, 1982
The date Prometh Plain 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 Prometh Plain. 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 Prometh Plain is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alpharma Us Pharmaceuticals Division
The full name of the firm holding legal responsibility for the new application of Prometh Plain.

Prometh Plain