Mucinex

   
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Mucinex


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

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

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

Strength - 600MG
The potency of the active ingredient(s), Guaifenesin. May repeat for multiple part products.

Applicant - ADAMS LABS INC
The firm name holding legal responsibility for Mucinex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021282
The FDA assigned number to Mucinex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mucinex. 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 - Jul 12, 2002
The date Mucinex 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 Mucinex. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Mucinex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Adams Laboratories Inc Dba Adams Respiratory Therapeutics
The full name of the firm holding legal responsibility for the new application of Mucinex.

Mucinex