Alinia

   
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Alinia


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

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

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

Strength - 100MG/5ML
The potency of the active ingredient(s), Nitazoxanide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021498
The FDA assigned number to Alinia. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Alinia. 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 - Nov 22, 2002
The date Alinia 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 Alinia. 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 Alinia is in. Format is RX, OTC, DISCN.

Applicant Full Name - Romark Laboratories
The full name of the firm holding legal responsibility for the new application of Alinia.

Alinia