Glyburide And Metformin Hcl


Glyburide And Metformin Hcl

Drug - Glyburide And Metformin Hcl
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Glyburide; Metformin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 1.25MG;250MG
The potency of the active ingredient(s), Glyburide; Metformin Hydrochloride. May repeat for multiple part products.

Applicant - TEVA
The firm name holding legal responsibility for Glyburide And Metformin Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076821
The FDA assigned number to Glyburide And Metformin Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Glyburide And Metformin Hcl. 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 - Jan 27, 2005
The date Glyburide And Metformin Hcl 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 Glyburide And Metformin Hcl. 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 Glyburide And Metformin Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Glyburide And Metformin Hcl.

Glyburide And Metformin Hcl