Nasarel

   
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Nasarel


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

Dosage - SPRAY, METERED; NASAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.029MG/SPRAY
The potency of the active ingredient(s), Flunisolide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020409
The FDA assigned number to Nasarel. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nasarel. 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 8, 1995
The date Nasarel 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 Nasarel. 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 Nasarel is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ivax Research Inc
The full name of the firm holding legal responsibility for the new application of Nasarel.

Nasarel