Metformin Hcl


Metformin Hcl

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

Strength - 1GM
The potency of the active ingredient(s), Metformin Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 075985
The FDA assigned number to Metformin Hcl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify 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 25, 2002
The date 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 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 Metformin Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sandoz Inc
The full name of the firm holding legal responsibility for the new application of Metformin Hcl.

Metformin Hcl