Luveris

   
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Luveris


Drug - Luveris
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) - Lutropin Alfa
Multiple ingredients are in alphabetical order.

Strength - 75 IU/VIAL
The potency of the active ingredient(s), Lutropin Alfa. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021322
The FDA assigned number to Luveris. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Luveris. 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 - Oct 8, 2004
The date Luveris 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 Luveris. 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 Luveris 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 Luveris.

Luveris