Nabumetone
Drug - Nabumetone
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) -
Nabumetone
Multiple ingredients are in alphabetical order.
Strength -
750MG
The potency of the active ingredient(s), Nabumetone. May repeat for multiple part products.
Applicant -
IVAX PHARMS
The firm name holding legal responsibility for Nabumetone. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
076009
The FDA assigned number to Nabumetone. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Nabumetone. 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 24, 2003
The date Nabumetone 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 Nabumetone. 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 Nabumetone is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Ivax Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Nabumetone.
Nabumetone
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