Humulin 50/50

   
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Humulin 50/50


Drug - Humulin 50/50
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 Recombinant Human; Insulin Susp Isophane Recombinant Human
Multiple ingredients are in alphabetical order.

Strength - 50 UNITS/ML;50 UNITS/ML
The potency of the active ingredient(s), Insulin Recombinant Human; Insulin Susp Isophane Recombinant Human. May repeat for multiple part products.

Applicant - LILLY
The firm name holding legal responsibility for Humulin 50/50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020100
The FDA assigned number to Humulin 50/50. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Humulin 50/50. 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 - Apr 29, 1992
The date Humulin 50/50 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) - Yes
The pioneer or innovator of Humulin 50/50. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Humulin 50/50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Eli Lilly And Co
The full name of the firm holding legal responsibility for the new application of Humulin 50/50.

Humulin 50/50