Duragesic-50

   
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Duragesic-50


Drug - Duragesic-50
The trade name of the product as shown on the labeling.

Dosage - FILM, EXTENDED RELEASE; TRANSDERMAL
The product dosage form and route separated by a semi-colon.

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

Strength - 50UGM/HR
The potency of the active ingredient(s), Fentanyl. May repeat for multiple part products.

Applicant - ALZA
The firm name holding legal responsibility for Duragesic-50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019813
The FDA assigned number to Duragesic-50. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Duragesic-50. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Aug 7, 1990
The date Duragesic-50 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 Duragesic-50. 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 Duragesic-50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alza Corp
The full name of the firm holding legal responsibility for the new application of Duragesic-50.

Duragesic-50