Lunesta

   
Google
 
Web NewDrugInformation.com

Lunesta


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 3MG
The potency of the active ingredient(s), Eszopiclone. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021476
The FDA assigned number to Lunesta. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Lunesta. 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 15, 2004
The date Lunesta 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 Lunesta. 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 Lunesta is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sepracor Pharmaceuticals
The full name of the firm holding legal responsibility for the new application of Lunesta.

Lunesta