Nebupent

   
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Nebupent


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

Dosage - FOR SOLUTION; INHALATION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Pentamidine Isethionate
Multiple ingredients are in alphabetical order.

Strength - 600MG/VIAL
The potency of the active ingredient(s), Pentamidine Isethionate. May repeat for multiple part products.

Applicant - AM PHARM PARTNERS
The firm name holding legal responsibility for Nebupent. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019887
The FDA assigned number to Nebupent. Format is nnnnnn.

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

Applicant Full Name - American Pharmaceutical Partners Inc
The full name of the firm holding legal responsibility for the new application of Nebupent.

Nebupent