Fortamet

   
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Fortamet


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

Applicant - ANDRX LABS LLC
The firm name holding legal responsibility for Fortamet. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021574
The FDA assigned number to Fortamet. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Fortamet. 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 - Apr 27, 2004
The date Fortamet 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 Fortamet. 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 Fortamet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Andrx Labs Llc
The full name of the firm holding legal responsibility for the new application of Fortamet.

Fortamet