Humatrope

   
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Humatrope


Drug - Humatrope
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) - Somatropin Recombinant
Multiple ingredients are in alphabetical order.

Strength - 5MG/VIAL
The potency of the active ingredient(s), Somatropin Recombinant. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019640
The FDA assigned number to Humatrope. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Humatrope. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - BX
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Mar 8, 1987
The date Humatrope 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 Humatrope. 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 Humatrope 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 Humatrope.

Humatrope