Citanest Plain

   
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Citanest Plain


Drug - Citanest Plain
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) - Prilocaine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 4%
The potency of the active ingredient(s), Prilocaine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 014763
The FDA assigned number to Citanest Plain. Format is nnnnnn.

Product Number - 007
The FDA assigned number to identify Citanest Plain. 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 Plain 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 Citanest Plain. 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 Citanest Plain is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Lp
The full name of the firm holding legal responsibility for the new application of Citanest Plain.

Citanest Plain