Silphen

   
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Silphen


Drug - Silphen
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 - SILARX
The firm name holding legal responsibility for Silphen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 072646
The FDA assigned number to Silphen. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Silphen. 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 27, 1992
The date Silphen 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 Silphen. 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 Silphen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Silarx Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Silphen.

Silphen