Forteo

   
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Forteo


Drug - Forteo
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; SUBCUTANEOUS
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Teriparatide Recombinant Human
Multiple ingredients are in alphabetical order.

Strength - EQ 0.75MG 3ML(0.25MG/ML)
The potency of the active ingredient(s), Teriparatide Recombinant Human. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021318
The FDA assigned number to Forteo. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Forteo. 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 - Nov 26, 2002
The date Forteo 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 Forteo. 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 Forteo 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 Forteo.

Forteo