Gonal-f

   
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Gonal-f


Drug - Gonal-f
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 - 75 IU/VIAL
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. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020378
The FDA assigned number to Gonal-f. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Gonal-f. 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 - Sep 29, 1997
The date Gonal-f 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 Gonal-f. 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 Gonal-f 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.

Gonal-f