Glucovance

   
Google
 
Web NewDrugInformation.com

Glucovance


Drug - Glucovance
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) - Glyburide; Metformin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2.5MG;500MG
The potency of the active ingredient(s), Glyburide; Metformin Hydrochloride. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Glucovance. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021178
The FDA assigned number to Glucovance. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Glucovance. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jul 31, 2000
The date Glucovance 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 Glucovance. 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 Glucovance is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Glucovance.

Glucovance