Micort-hc

   
Google
 
Web NewDrugInformation.com

Micort-hc


Drug - Micort-hc
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) - Hydrocortisone Acetate
Multiple ingredients are in alphabetical order.

Strength - 2.5%
The potency of the active ingredient(s), Hydrocortisone Acetate. May repeat for multiple part products.

Applicant - FERNDALE LABS
The firm name holding legal responsibility for Micort-hc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040396
The FDA assigned number to Micort-hc. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Micort-hc. 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 - Feb 27, 2001
The date Micort-hc 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 Micort-hc. 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 Micort-hc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ferndale Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Micort-hc.

Micort-hc