Etrafon 2-10

   
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Etrafon 2-10


Drug - Etrafon 2-10
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Amitriptyline Hydrochloride; Perphenazine
Multiple ingredients are in alphabetical order.

Strength - 10MG;2MG
The potency of the active ingredient(s), Amitriptyline Hydrochloride; Perphenazine. May repeat for multiple part products.

Applicant - SCHERING
The firm name holding legal responsibility for Etrafon 2-10. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 014713
The FDA assigned number to Etrafon 2-10. Format is nnnnnn.

Product Number - 007
The FDA assigned number to identify Etrafon 2-10. 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 - Approved Prior to Jan 1, 1982
The date Etrafon 2-10 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 Etrafon 2-10. 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 Etrafon 2-10 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Corp Sub Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of Etrafon 2-10.

Etrafon 2-10