Nutrestore

   
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Nutrestore


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

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

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

Strength - 5GM/PACKET
The potency of the active ingredient(s), Glutamine. May repeat for multiple part products.

Applicant - NUTRITIONAL RESTART
The firm name holding legal responsibility for Nutrestore. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021667
The FDA assigned number to Nutrestore. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nutrestore. 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 - Jun 10, 2004
The date Nutrestore 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 Nutrestore. 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 Nutrestore is in. Format is RX, OTC, DISCN.

Applicant Full Name - Nutritional Restart Pharmaceutical Lp
The full name of the firm holding legal responsibility for the new application of Nutrestore.

Nutrestore