Oxistat
Drug - Oxistat
The trade name of the product as shown on the labeling.
Dosage -
LOTION; TOPICAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Oxiconazole Nitrate
Multiple ingredients are in alphabetical order.
Strength -
EQ 1% BASE
The potency of the active ingredient(s), Oxiconazole Nitrate. May repeat for multiple part products.
Applicant -
ALTANA
The firm name holding legal responsibility for Oxistat. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020209
The FDA assigned number to Oxistat. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Oxistat. 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 -
Sep 30, 1992
The date Oxistat 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 Oxistat. 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 Oxistat is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Altana Inc
The full name of the firm holding legal responsibility for the new application of Oxistat.
Oxistat
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