Lutrepulse Kit

   
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Lutrepulse Kit


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

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

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

Strength - 3.2MG/VIAL
The potency of the active ingredient(s), Gonadorelin Acetate. May repeat for multiple part products.

Applicant - FERRING
The firm name holding legal responsibility for Lutrepulse Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019687
The FDA assigned number to Lutrepulse Kit. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Lutrepulse Kit. 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 10, 1989
The date Lutrepulse Kit 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 Lutrepulse Kit. 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 Lutrepulse Kit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ferring Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Lutrepulse Kit.

Lutrepulse Kit