Trialodine
Drug - Trialodine
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) -
Trazodone Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
50MG
The potency of the active ingredient(s), Trazodone Hydrochloride. May repeat for multiple part products.
Applicant -
QUANTUM PHARMICS
The firm name holding legal responsibility for Trialodine. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
070942
The FDA assigned number to Trialodine. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Trialodine. 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 1, 1986
The date Trialodine 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 Trialodine. 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 Trialodine is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Quantum Pharmics Ltd
The full name of the firm holding legal responsibility for the new application of Trialodine.
Trialodine
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