Nalfon 200

   
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Nalfon 200


Drug - Nalfon 200
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Fenoprofen Calcium
Multiple ingredients are in alphabetical order.

Strength - EQ 200MG BASE
The potency of the active ingredient(s), Fenoprofen Calcium. May repeat for multiple part products.

Applicant - PEDINOL
The firm name holding legal responsibility for Nalfon 200. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017604
The FDA assigned number to Nalfon 200. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Nalfon 200. 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 - Approved Prior to Jan 1, 1982
The date Nalfon 200 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 Nalfon 200. 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 Nalfon 200 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pedinol Pharmacal Inc
The full name of the firm holding legal responsibility for the new application of Nalfon 200.

Nalfon 200