Humalog Pen

   
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Humalog Pen


Drug - Humalog Pen
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 Lispro Recombinant
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 020563
The FDA assigned number to Humalog Pen. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Humalog Pen. 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 - Aug 6, 1998
The date Humalog Pen 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 Humalog Pen. 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 Humalog Pen 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 Humalog Pen.

Humalog Pen