Chirocaine

   
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Chirocaine


Drug - Chirocaine
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) - Levobupivacaine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 5MG BASE/ML
The potency of the active ingredient(s), Levobupivacaine Hydrochloride. May repeat for multiple part products.

Applicant - PURDUE PHARMA LP
The firm name holding legal responsibility for Chirocaine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020997
The FDA assigned number to Chirocaine. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Chirocaine. 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 - Aug 5, 1999
The date Chirocaine 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 Chirocaine. 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 Chirocaine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Purdue Pharma Lp
The full name of the firm holding legal responsibility for the new application of Chirocaine.

Chirocaine