Actahist

   
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Actahist


Drug - Actahist
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) - Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 30MG/5ML;1.25MG/5ML
The potency of the active ingredient(s), Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 088344
The FDA assigned number to Actahist. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Actahist. 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 - Feb 9, 1984
The date Actahist 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 Actahist. 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 Actahist is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hr Cenci Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Actahist.

Actahist