Codrix

   
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Codrix


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

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

Active Ingredient(s) - Acetaminophen; Codeine Phosphate
Multiple ingredients are in alphabetical order.

Strength - 500MG;30MG
The potency of the active ingredient(s), Acetaminophen; Codeine Phosphate. May repeat for multiple part products.

Applicant - ANDRX PHARMS
The firm name holding legal responsibility for Codrix. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 040441
The FDA assigned number to Codrix. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Codrix. 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 - Mar 27, 2003
The date Codrix 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 Codrix. 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 Codrix is in. Format is RX, OTC, DISCN.

Applicant Full Name - Andrx Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Codrix.

Codrix