Benadryl Preservative Free


Benadryl Preservative Free

Drug - Benadryl Preservative Free
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

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

Strength - 50MG/ML
The potency of the active ingredient(s), Diphenhydramine Hydrochloride. May repeat for multiple part products.

Applicant - PARKE DAVIS
The firm name holding legal responsibility for Benadryl Preservative Free. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 009486
The FDA assigned number to Benadryl Preservative Free. Format is nnnnnn.

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

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

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

Applicant Full Name - Parke Davis Div Warner Lambert Co
The full name of the firm holding legal responsibility for the new application of Benadryl Preservative Free.

Benadryl Preservative Free