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

The product dosage form and route separated by a semi-colon.

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

Strength - 200 UNITS/VIAL
The potency of the active ingredient(s), Teriparatide Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019498
The FDA assigned number to Parathar. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Parathar. 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 - Dec 23, 1987
The date Parathar 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 Parathar. 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 Parathar is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Parathar.