Fentanyl Citrate Preservative Free

   
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Fentanyl Citrate Preservative Free


Drug - Fentanyl Citrate Preservative Free
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 - MARSAM PHARMS LLC
The firm name holding legal responsibility for Fentanyl Citrate Preservative Free. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074917
The FDA assigned number to Fentanyl Citrate Preservative Free. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fentanyl Citrate Preservative Free. 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 - Feb 3, 1998
The date Fentanyl Citrate Preservative Free 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 Preservative Free. 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 Citrate Preservative Free is in. Format is RX, OTC, DISCN.

Applicant Full Name - Marsam Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Fentanyl Citrate Preservative Free.

Fentanyl Citrate Preservative Free