Ambisome

   
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Ambisome


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

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

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

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

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

New Drug Application (NDA) Number - 050740
The FDA assigned number to Ambisome. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ambisome. 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 - Aug 11, 1997
The date Ambisome 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 Ambisome. 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 Ambisome 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 Ambisome.

Ambisome