Polocaine W/ Levonordefrin

   
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Polocaine W/ Levonordefrin


Drug - Polocaine W/ Levonordefrin
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) - Levonordefrin; Mepivacaine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 0.05MG/ML;2%
The potency of the active ingredient(s), Levonordefrin; Mepivacaine Hydrochloride. May repeat for multiple part products.

Applicant - DENTSPLY PHARM
The firm name holding legal responsibility for Polocaine W/ Levonordefrin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089517
The FDA assigned number to Polocaine W/ Levonordefrin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Polocaine W/ Levonordefrin. 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 - Apr 14, 1988
The date Polocaine W/ Levonordefrin 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 Polocaine W/ Levonordefrin. 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 Polocaine W/ Levonordefrin 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 Polocaine W/ Levonordefrin.

Polocaine W/ Levonordefrin