Thermazene
Drug - Thermazene
The trade name of the product as shown on the labeling.
Dosage -
CREAM; TOPICAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Silver Sulfadiazine
Multiple ingredients are in alphabetical order.
Strength -
1%
The potency of the active ingredient(s), Silver Sulfadiazine. May repeat for multiple part products.
Applicant -
KENDALL LP
The firm name holding legal responsibility for Thermazene. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018810
The FDA assigned number to Thermazene. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Thermazene. 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 -
Dec 23, 1985
The date Thermazene 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 Thermazene. 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 Thermazene is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Kendall Co Lp
The full name of the firm holding legal responsibility for the new application of Thermazene.
Thermazene
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