Felbatol
Drug - Felbatol
The trade name of the product as shown on the labeling.
Dosage -
SUSPENSION; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Felbamate
Multiple ingredients are in alphabetical order.
Strength -
600MG/5ML
The potency of the active ingredient(s), Felbamate. May repeat for multiple part products.
Applicant -
MEDPOINTE
The firm name holding legal responsibility for Felbatol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020189
The FDA assigned number to Felbatol. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Felbatol. 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 -
Jul 29, 1993
The date Felbatol 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 Felbatol. 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 Felbatol is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Medpointe Healthcare Inc
The full name of the firm holding legal responsibility for the new application of Felbatol.
Felbatol
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