Fazaclo Odt

   
Google
 
Web NewDrugInformation.com

Fazaclo Odt


Drug - Fazaclo Odt
The trade name of the product as shown on the labeling.

Dosage - TABLET, ORALLY DISINTEGRATING; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 50MG
The potency of the active ingredient(s), Clozapine. May repeat for multiple part products.

Applicant - ALAMO PHARMS
The firm name holding legal responsibility for Fazaclo Odt. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021590
The FDA assigned number to Fazaclo Odt. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Fazaclo Odt. 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 - Jun 3, 2005
The date Fazaclo Odt 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 Fazaclo Odt. 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 Fazaclo Odt is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alamo Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Fazaclo Odt.

Fazaclo Odt