Kenalog-10
Drug - Kenalog-10
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Triamcinolone Acetonide
Multiple ingredients are in alphabetical order.
Strength -
10MG/ML
The potency of the active ingredient(s), Triamcinolone Acetonide. May repeat for multiple part products.
Applicant -
APOTHECON
The firm name holding legal responsibility for Kenalog-10. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
012041
The FDA assigned number to Kenalog-10. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Kenalog-10. 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 Kenalog-10 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 Kenalog-10. 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 Kenalog-10 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Kenalog-10.
Kenalog-10
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