Ambien

   
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Ambien


Drug - Ambien
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) - Zolpidem Tartrate
Multiple ingredients are in alphabetical order.

Strength - 10MG
The potency of the active ingredient(s), Zolpidem Tartrate. May repeat for multiple part products.

Applicant - SANOFI SYNTHELABO
The firm name holding legal responsibility for Ambien. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019908
The FDA assigned number to Ambien. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Ambien. 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 16, 1992
The date Ambien 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 Ambien. 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 Ambien is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Ambien.

Ambien