Septocaine

   
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Septocaine


Drug - Septocaine
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) - Articaine Hydrochloride; Epinephrine
Multiple ingredients are in alphabetical order.

Strength - 4%;EQ 0.01MG BASE/ML
The potency of the active ingredient(s), Articaine Hydrochloride; Epinephrine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020971
The FDA assigned number to Septocaine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Septocaine. 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 - Apr 3, 2000
The date Septocaine 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 Septocaine. 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 Septocaine is in. Format is RX, OTC, DISCN.

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

Septocaine