Promethazine Plain

   
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Promethazine Plain


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

New Drug Application (NDA) Number - 087953
The FDA assigned number to Promethazine Plain. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Promethazine Plain. 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 - Nov 15, 1982
The date Promethazine 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) - Yes
The pioneer or innovator of Promethazine Plain. 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 Promethazine Plain 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 Promethazine Plain.

Promethazine Plain