Ultralente

   
Google
 
Web NewDrugInformation.com

Ultralente


Drug - Ultralente
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) - Insulin Zinc Susp Extended Purified Beef
Multiple ingredients are in alphabetical order.

Strength - 100 UNITS/ML
The potency of the active ingredient(s), Insulin Zinc Susp Extended Purified Beef. May repeat for multiple part products.

Applicant - NOVO NORDISK INC
The firm name holding legal responsibility for Ultralente. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018385
The FDA assigned number to Ultralente. Format is nnnnnn.

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

Applicant Full Name - Novo Nordisk Inc
The full name of the firm holding legal responsibility for the new application of Ultralente.

Ultralente