Silvadene
Drug - Silvadene
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 -
KING PHARMS
The firm name holding legal responsibility for Silvadene. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
017381
The FDA assigned number to Silvadene. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Silvadene. 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 -
Approved Prior to Jan 1, 1982
The date Silvadene 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 Silvadene. 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 Silvadene is in. Format is RX, OTC, DISCN.
Applicant Full Name -
King Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Silvadene.
Silvadene
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