Glumetza

   
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Glumetza


Drug - Glumetza
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) - Metformin Hydrochloride
Multiple ingredients are in alphabetical order.

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

Applicant - BIOVAIL
The firm name holding legal responsibility for Glumetza. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021748
The FDA assigned number to Glumetza. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Glumetza. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jun 3, 2005
The date Glumetza 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 Glumetza. 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 Glumetza is in. Format is RX, OTC, DISCN.

Applicant Full Name - Biovail Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Glumetza.

Glumetza