Dexacort

   
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Dexacort


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

Dosage - AEROSOL; NASAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Dexamethasone Sodium Phosphate
Multiple ingredients are in alphabetical order.

Strength - EQ 0.1MG PHOSPHATE/INH
The potency of the active ingredient(s), Dexamethasone Sodium Phosphate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 014242
The FDA assigned number to Dexacort. Format is nnnnnn.

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

Applicant Full Name - Ucb Pharma Inc
The full name of the firm holding legal responsibility for the new application of Dexacort.

Dexacort