Trelstar Depot

   
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Trelstar Depot


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

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

Active Ingredient(s) - Triptorelin Pamoate
Multiple ingredients are in alphabetical order.

Strength - EQ 3.75MG BASE/VIAL
The potency of the active ingredient(s), Triptorelin Pamoate. May repeat for multiple part products.

Applicant - WATSON LABS
The firm name holding legal responsibility for Trelstar Depot. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020715
The FDA assigned number to Trelstar Depot. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Trelstar Depot. 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 - Jun 15, 2000
The date Trelstar Depot 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 Trelstar Depot. 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 Trelstar Depot is in. Format is RX, OTC, DISCN.

Applicant Full Name - Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Trelstar Depot.

Trelstar Depot