Web NewDrugInformation.com


Drug - Levo-dromoran
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) - Levorphanol Tartrate
Multiple ingredients are in alphabetical order.

Strength - 2MG/ML
The potency of the active ingredient(s), Levorphanol Tartrate. May repeat for multiple part products.

The firm name holding legal responsibility for Levo-dromoran. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 008719
The FDA assigned number to Levo-dromoran. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Levo-dromoran. 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 19, 1991
The date Levo-dromoran 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 Levo-dromoran. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Levo-dromoran is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Levo-dromoran.