Gabapentin

   
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Gabapentin


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

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

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

Strength - 600MG
The potency of the active ingredient(s), Gabapentin. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076017
The FDA assigned number to Gabapentin. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Gabapentin. 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 - Apr 29, 2005
The date Gabapentin 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 Gabapentin. 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 Gabapentin is in. Format is RX, OTC, DISCN.

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

Gabapentin