Octocaine

   
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Octocaine


Drug - Octocaine
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) - Epinephrine; Lidocaine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.02MG/ML;2%
The potency of the active ingredient(s), Epinephrine; Lidocaine Hydrochloride. May repeat for multiple part products.

Applicant - SEPTODONT
The firm name holding legal responsibility for Octocaine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 084048
The FDA assigned number to Octocaine. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Octocaine. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Octocaine 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 Octocaine. 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 Octocaine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Septodont Inc
The full name of the firm holding legal responsibility for the new application of Octocaine.

Octocaine