Lotusate
Drug - Lotusate
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) -
Talbutal
Multiple ingredients are in alphabetical order.
Strength -
120MG
The potency of the active ingredient(s), Talbutal. May repeat for multiple part products.
Applicant -
SANOFI SYNTHELABO
The firm name holding legal responsibility for Lotusate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
009410
The FDA assigned number to Lotusate. Format is nnnnnn.
Product Number -
005
The FDA assigned number to identify Lotusate. 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 -
Approved Prior to Jan 1, 1982
The date Lotusate 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 Lotusate. 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 Lotusate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Lotusate.
Lotusate
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