Droxia

   
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Droxia


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

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

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

Strength - 400MG
The potency of the active ingredient(s), Hydroxyurea. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Droxia. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016295
The FDA assigned number to Droxia. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Droxia. 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 25, 1998
The date Droxia 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) - Yes
The pioneer or innovator of Droxia. 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 Droxia is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Co
The full name of the firm holding legal responsibility for the new application of Droxia.

Droxia