Fertinex

   
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Fertinex


Drug - Fertinex
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; SUBCUTANEOUS
The product dosage form and route separated by a semi-colon.

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

Strength - 150 IU/AMP
The potency of the active ingredient(s), Urofollitropin. May repeat for multiple part products.

Applicant - SERONO
The firm name holding legal responsibility for Fertinex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019415
The FDA assigned number to Fertinex. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Fertinex. 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 - Aug 23, 1996
The date Fertinex 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 Fertinex. 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 Fertinex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Serono Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Fertinex.

Fertinex