Naproxen Sodium

   
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Naproxen Sodium


Drug - Naproxen Sodium
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) - Naproxen Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 250MG BASE
The potency of the active ingredient(s), Naproxen Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 074230
The FDA assigned number to Naproxen Sodium. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Naproxen Sodium. 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 14, 1995
The date Naproxen Sodium 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 Naproxen Sodium. 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 Naproxen Sodium 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 Naproxen Sodium.

Naproxen Sodium