Suboxone

   
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Suboxone


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

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

Active Ingredient(s) - Buprenorphine Hydrochloride; Naloxone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 2MG;0.5MG
The potency of the active ingredient(s), Buprenorphine Hydrochloride; Naloxone Hydrochloride. May repeat for multiple part products.

Applicant - RECKITT BENCKISER
The firm name holding legal responsibility for Suboxone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020733
The FDA assigned number to Suboxone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Suboxone. 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 - Oct 8, 2002
The date Suboxone 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 Suboxone. 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 Suboxone is in. Format is RX, OTC, DISCN.

Applicant Full Name - Reckitt Benckiser Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Suboxone.

Suboxone