Amphotec

   
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Amphotec


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

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

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

Strength - 100MG/VIAL
The potency of the active ingredient(s), Amphotericin B. May repeat for multiple part products.

Applicant - THREE RIVERS PHARMS
The firm name holding legal responsibility for Amphotec. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050729
The FDA assigned number to Amphotec. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Amphotec. 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 - Nov 22, 1996
The date Amphotec 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 Amphotec. 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 Amphotec is in. Format is RX, OTC, DISCN.

Applicant Full Name - Three Rivers Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Amphotec.

Amphotec