Epicort
Drug - Epicort
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) -
Hydrocortisone
Multiple ingredients are in alphabetical order.
Strength -
0.5%
The potency of the active ingredient(s), Hydrocortisone. May repeat for multiple part products.
Applicant -
BLULINE
The firm name holding legal responsibility for Epicort. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
083219
The FDA assigned number to Epicort. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Epicort. 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 Epicort 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 Epicort. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Epicort is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Bluline Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Epicort.
Epicort
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