Fentanyl

   
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Fentanyl


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

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

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

Strength - EQ 0.4MG BASE
The potency of the active ingredient(s), Fentanyl Citrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020195
The FDA assigned number to Fentanyl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Fentanyl. 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 - Oct 4, 1993
The date Fentanyl 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 Fentanyl. 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 Fentanyl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Anesta Corp
The full name of the firm holding legal responsibility for the new application of Fentanyl.

Fentanyl