Citanest Forte

   
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Citanest Forte


Drug - Citanest Forte
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 Bitartrate; Prilocaine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.005MG/ML;4%
The potency of the active ingredient(s), Epinephrine Bitartrate; Prilocaine Hydrochloride. May repeat for multiple part products.

Applicant - DENTSPLY PHARM
The firm name holding legal responsibility for Citanest Forte. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021383
The FDA assigned number to Citanest Forte. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Citanest Forte. 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 - Approved Prior to Jan 1, 1982
The date Citanest Forte 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 Citanest Forte. 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 Citanest Forte is in. Format is RX, OTC, DISCN.

Applicant Full Name - Dentsply Pharmaceutical
The full name of the firm holding legal responsibility for the new application of Citanest Forte.

Citanest Forte