Cortalone

   
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Cortalone


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 5MG
The potency of the active ingredient(s), Prednisolone. May repeat for multiple part products.

Applicant - HALSEY
The firm name holding legal responsibility for Cortalone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 080304
The FDA assigned number to Cortalone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cortalone. 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 Cortalone 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 Cortalone. 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 Cortalone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Halsey Drug Co Inc
The full name of the firm holding legal responsibility for the new application of Cortalone.

Cortalone