Factrel

   
Google
 
Web NewDrugInformation.com

Factrel


Drug - Factrel
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 Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 0.1MG BASE/VIAL
The potency of the active ingredient(s), Gonadorelin Hydrochloride. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE CORP
The firm name holding legal responsibility for Factrel. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018123
The FDA assigned number to Factrel. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Factrel. 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 30, 1982
The date Factrel 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 Factrel. 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 Factrel is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp Anesthesia Critical Care
The full name of the firm holding legal responsibility for the new application of Factrel.

Factrel