Fentanyl Citrate

   
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Fentanyl Citrate


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

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

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

Strength - EQ 0.05MG BASE/ML
The potency of the active ingredient(s), Fentanyl Citrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019115
The FDA assigned number to Fentanyl Citrate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fentanyl Citrate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jan 12, 1985
The date Fentanyl Citrate 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 Citrate. 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 Fentanyl Citrate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hospira Inc
The full name of the firm holding legal responsibility for the new application of Fentanyl Citrate.

Fentanyl Citrate