Vospire Er

   
Google
 
Web NewDrugInformation.com

Vospire Er


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

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

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

Strength - EQ 8MG BASE
The potency of the active ingredient(s), Albuterol Sulfate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076130
The FDA assigned number to Vospire Er. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Vospire 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 - Sep 26, 2002
The date Vospire 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) - Yes
The pioneer or innovator of Vospire 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 Vospire Er is in. Format is RX, OTC, DISCN.

Applicant Full Name - Odyssey Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Vospire Er.

Vospire Er