Mycamine

   
Google
 
Web NewDrugInformation.com

Mycamine


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

Dosage - INJECTABLE; IV (INFUSION)
The product dosage form and route separated by a semi-colon.

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

Strength - 50MG/VIAL
The potency of the active ingredient(s), Micafungin Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021506
The FDA assigned number to Mycamine. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Mycamine. 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 - Mar 16, 2005
The date Mycamine 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 Mycamine. 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 Mycamine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astellas Pharma Us Inc
The full name of the firm holding legal responsibility for the new application of Mycamine.

Mycamine