Colocort
Drug - Colocort
The trade name of the product as shown on the labeling.
Dosage -
ENEMA; RECTAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Hydrocortisone
Multiple ingredients are in alphabetical order.
Strength -
100MG/60ML
The potency of the active ingredient(s), Hydrocortisone. May repeat for multiple part products.
Applicant -
PADDOCK
The firm name holding legal responsibility for Colocort. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075172
The FDA assigned number to Colocort. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Colocort. 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 3, 1999
The date Colocort 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 Colocort. 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 Colocort is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Paddock Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Colocort.
Colocort
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