Aciphex

   
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Aciphex


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

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

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

Strength - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
The potency of the active ingredient(s), Rabeprazole Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020973
The FDA assigned number to Aciphex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Aciphex. 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 - May 29, 2002
The date Aciphex 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 Aciphex. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Aciphex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Eisai Medical Research Inc
The full name of the firm holding legal responsibility for the new application of Aciphex.

Aciphex