Vicks Formula 44

   
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Vicks Formula 44


Drug - Vicks Formula 44
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) - Diphenhydramine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 12.5MG/5ML
The potency of the active ingredient(s), Diphenhydramine Hydrochloride. May repeat for multiple part products.

Applicant - PROCTER AND GAMBLE
The firm name holding legal responsibility for Vicks Formula 44. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 070524
The FDA assigned number to Vicks Formula 44. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Vicks Formula 44. 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 14, 1987
The date Vicks Formula 44 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 Vicks Formula 44. 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 Vicks Formula 44 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Procter And Gamble Co
The full name of the firm holding legal responsibility for the new application of Vicks Formula 44.

Vicks Formula 44