Fluvoxamine Maleate

   
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Fluvoxamine Maleate


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Fluvoxamine Maleate
Multiple ingredients are in alphabetical order.

Strength - 25MG
The potency of the active ingredient(s), Fluvoxamine Maleate. May repeat for multiple part products.

Applicant - IVAX PHARMS
The firm name holding legal responsibility for Fluvoxamine Maleate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075898
The FDA assigned number to Fluvoxamine Maleate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Fluvoxamine Maleate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Mar 12, 2001
The date Fluvoxamine Maleate 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 Fluvoxamine Maleate. 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 Fluvoxamine Maleate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ivax Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Fluvoxamine Maleate.

Fluvoxamine Maleate