Ganirelix Acetate Injection

   
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Ganirelix Acetate Injection


Drug - Ganirelix Acetate Injection
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) - Ganirelix Acetate
Multiple ingredients are in alphabetical order.

Strength - EQ 250UGM BASE/0.5ML
The potency of the active ingredient(s), Ganirelix Acetate. May repeat for multiple part products.

Applicant - ORGANON USA INC
The firm name holding legal responsibility for Ganirelix Acetate Injection. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021057
The FDA assigned number to Ganirelix Acetate Injection. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ganirelix Acetate Injection. 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 - Jul 29, 1999
The date Ganirelix Acetate Injection 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 Ganirelix Acetate Injection. 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 Ganirelix Acetate Injection is in. Format is RX, OTC, DISCN.

Applicant Full Name - Organon Usa Inc
The full name of the firm holding legal responsibility for the new application of Ganirelix Acetate Injection.

Ganirelix Acetate Injection