Lidocaine Viscous
Drug - Lidocaine Viscous
The trade name of the product as shown on the labeling.
Dosage -
SOLUTION; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Lidocaine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
2%
The potency of the active ingredient(s), Lidocaine Hydrochloride. May repeat for multiple part products.
Applicant -
ROXANE
The firm name holding legal responsibility for Lidocaine Viscous. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
088802
The FDA assigned number to Lidocaine Viscous. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Lidocaine Viscous. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Apr 26, 1985
The date Lidocaine Viscous 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 Lidocaine Viscous. 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 Lidocaine Viscous is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Lidocaine Viscous.
Lidocaine Viscous
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