Azmacort
Drug - Azmacort
The trade name of the product as shown on the labeling.
Dosage -
AEROSOL, METERED; INHALATION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Triamcinolone Acetonide
Multiple ingredients are in alphabetical order.
Strength -
0.1MG/INH
The potency of the active ingredient(s), Triamcinolone Acetonide. May repeat for multiple part products.
Applicant -
KOS LIFE
The firm name holding legal responsibility for Azmacort. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018117
The FDA assigned number to Azmacort. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Azmacort. 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 -
Apr 23, 1982
The date Azmacort 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 Azmacort. 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 Azmacort is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Kos Life Sciences Inc
The full name of the firm holding legal responsibility for the new application of Azmacort.
Azmacort
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