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Drug - Hydramine
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.

The firm name holding legal responsibility for Hydramine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 070205
The FDA assigned number to Hydramine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hydramine. 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 28, 1986
The date Hydramine 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 Hydramine. 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 Hydramine 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 Hydramine.