Amphotericin B

   
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Amphotericin B


Drug - Amphotericin B
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) - 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 - ABBOTT
The firm name holding legal responsibility for Amphotericin B. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 064141
The FDA assigned number to Amphotericin B. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Amphotericin B. 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 - Dec 23, 1996
The date Amphotericin B 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 Amphotericin B. 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 Amphotericin B is in. Format is RX, OTC, DISCN.

Applicant Full Name - Abbott Laboratories
The full name of the firm holding legal responsibility for the new application of Amphotericin B.

Amphotericin B