Naropin

   
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Naropin


Drug - Naropin
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) - Ropivacaine Hydrochloride Monohydrate
Multiple ingredients are in alphabetical order.

Strength - 2MG/ML
The potency of the active ingredient(s), Ropivacaine Hydrochloride Monohydrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020533
The FDA assigned number to Naropin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Naropin. 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 - Sep 24, 1996
The date Naropin 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 Naropin. 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 Naropin 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 Naropin.

Naropin