Razadyne Er

   
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Razadyne Er


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

Dosage - CAPSULE, EXTENDED RELEASE; 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 24MG BASE
The potency of the active ingredient(s), Galantamine Hydrobromide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021615
The FDA assigned number to Razadyne Er. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Razadyne Er. 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 - Dec 22, 2004
The date Razadyne Er 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 Razadyne Er. 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 Er is in. Format is RX, OTC, DISCN.

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

Razadyne Er