Femstat
Drug - Femstat
The trade name of the product as shown on the labeling.
Dosage -
SUPPOSITORY; VAGINAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Butoconazole Nitrate
Multiple ingredients are in alphabetical order.
Strength -
100MG
The potency of the active ingredient(s), Butoconazole Nitrate. May repeat for multiple part products.
Applicant -
ROCHE PALO
The firm name holding legal responsibility for Femstat. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019359
The FDA assigned number to Femstat. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Femstat. 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 -
Nov 25, 1985
The date Femstat 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 Femstat. 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 Femstat is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Roche Palo Alto Llc
The full name of the firm holding legal responsibility for the new application of Femstat.
Femstat
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