Gabapetin
Drug - Gabapetin
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Gabapentin
Multiple ingredients are in alphabetical order.
Strength -
300MG
The potency of the active ingredient(s), Gabapentin. May repeat for multiple part products.
Applicant -
TEVA PHARMS
The firm name holding legal responsibility for Gabapetin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075435
The FDA assigned number to Gabapetin. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Gabapetin. 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 -
Oct 8, 2004
The date Gabapetin 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 Gabapetin. 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 Gabapetin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Teva Pharmaceuticals Usa
The full name of the firm holding legal responsibility for the new application of Gabapetin.
Gabapetin
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