Razadyne

   
Google
 
Web NewDrugInformation.com

Razadyne


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

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

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

Strength - EQ 4MG BASE
The potency of the active ingredient(s), Galantamine Hydrobromide. May repeat for multiple part products.

Applicant - JANSSEN PHARMA
The firm name holding legal responsibility for Razadyne. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021169
The FDA assigned number to Razadyne. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Razadyne. 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 - Feb 28, 2001
The date Razadyne 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 Razadyne. 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 Razadyne is in. Format is RX, OTC, DISCN.

Applicant Full Name - Janssen Pharmaceutica Products Lp
The full name of the firm holding legal responsibility for the new application of Razadyne.

Razadyne