Inomax
Drug - Inomax
The trade name of the product as shown on the labeling.
Dosage -
GAS; INHALATION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Nitric Oxide
Multiple ingredients are in alphabetical order.
Strength -
800PPM
The potency of the active ingredient(s), Nitric Oxide. May repeat for multiple part products.
Applicant -
INO
The firm name holding legal responsibility for Inomax. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020845
The FDA assigned number to Inomax. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Inomax. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Dec 23, 1999
The date Inomax 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 Inomax. 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 Inomax is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Ino Therapeutics Inc
The full name of the firm holding legal responsibility for the new application of Inomax.
Inomax
|
