Arestin

   
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Arestin


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

Dosage - POWDER, EXTENDED RELEASE; DENTAL
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 1MG BASE
The potency of the active ingredient(s), Minocycline Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050781
The FDA assigned number to Arestin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Arestin. 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 16, 2001
The date Arestin 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 Arestin. 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 Arestin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Orapharma Inc
The full name of the firm holding legal responsibility for the new application of Arestin.

Arestin