Abelcet

   
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Abelcet


Drug - Abelcet
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 - 5MG/ML
The potency of the active ingredient(s), Amphotericin B. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050724
The FDA assigned number to Abelcet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Abelcet. 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 20, 1995
The date Abelcet 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 Abelcet. 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 Abelcet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Enzon Inc
The full name of the firm holding legal responsibility for the new application of Abelcet.

Abelcet