Priscoline
Drug - Priscoline
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Tolazoline Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
25MG/ML
The potency of the active ingredient(s), Tolazoline Hydrochloride. May repeat for multiple part products.
Applicant -
NOVARTIS
The firm name holding legal responsibility for Priscoline. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
006403
The FDA assigned number to Priscoline. Format is nnnnnn.
Product Number -
005
The FDA assigned number to identify Priscoline. 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 -
Feb 22, 1985
The date Priscoline 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 Priscoline. 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 Priscoline is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Priscoline.
Priscoline
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