Hydrocortisone Valerate

   
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Hydrocortisone Valerate


Drug - Hydrocortisone Valerate
The trade name of the product as shown on the labeling.

Dosage - OINTMENT; TOPICAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Hydrocortisone Valerate
Multiple ingredients are in alphabetical order.

Strength - 0.2%
The potency of the active ingredient(s), Hydrocortisone Valerate. May repeat for multiple part products.

Applicant - ALTANA
The firm name holding legal responsibility for Hydrocortisone Valerate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075085
The FDA assigned number to Hydrocortisone Valerate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hydrocortisone Valerate. 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 - Jul 31, 2001
The date Hydrocortisone Valerate 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 Hydrocortisone Valerate. 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 Hydrocortisone Valerate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Altana Inc
The full name of the firm holding legal responsibility for the new application of Hydrocortisone Valerate.

Hydrocortisone Valerate