Innovar

   
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Innovar


Drug - Innovar
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) - Droperidol; Fentanyl Citrate
Multiple ingredients are in alphabetical order.

Strength - 2.5MG/ML;EQ 0.05MG BASE/ML
The potency of the active ingredient(s), Droperidol; Fentanyl Citrate. May repeat for multiple part products.

Applicant - AKORN MFG
The firm name holding legal responsibility for Innovar. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016049
The FDA assigned number to Innovar. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Innovar. 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 Innovar 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 Innovar. 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 Innovar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Akorn Manufacturing Inc
The full name of the firm holding legal responsibility for the new application of Innovar.

Innovar