Nexium

   
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Nexium


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

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

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

Strength - EQ 40MG BASE
The potency of the active ingredient(s), Esomeprazole Magnesium. May repeat for multiple part products.

Applicant - ASTRAZENECA
The firm name holding legal responsibility for Nexium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021153
The FDA assigned number to Nexium. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Nexium. 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 - Feb 20, 2001
The date Nexium 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 Nexium. 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 Nexium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Lp
The full name of the firm holding legal responsibility for the new application of Nexium.

Nexium