Regular Insulin

   
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Regular Insulin


Drug - Regular Insulin
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 Pork
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 017926
The FDA assigned number to Regular Insulin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Regular Insulin. 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 Regular Insulin 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 Regular Insulin. 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 Regular Insulin 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 Regular Insulin.

Regular Insulin