Gonal-f Rff Pen

   
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Gonal-f Rff Pen


Drug - Gonal-f Rff Pen
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) - Follitropin Alfa/beta
Multiple ingredients are in alphabetical order.

Strength - 900 IU/1.5ML
The potency of the active ingredient(s), Follitropin Alfa/beta. May repeat for multiple part products.

Applicant - SERONO INC
The firm name holding legal responsibility for Gonal-f Rff Pen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021684
The FDA assigned number to Gonal-f Rff Pen. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Gonal-f Rff Pen. 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 - May 25, 2004
The date Gonal-f Rff Pen 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 Gonal-f Rff Pen. 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 Gonal-f Rff Pen is in. Format is RX, OTC, DISCN.

Applicant Full Name - Serono Inc
The full name of the firm holding legal responsibility for the new application of Gonal-f Rff Pen.

Gonal-f Rff Pen