Mucinex Dm

   
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Mucinex Dm


Drug - Mucinex Dm
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) - Dextromethorphan Hydrobromide; Guaifenesin
Multiple ingredients are in alphabetical order.

Strength - 60MG;1.2GM
The potency of the active ingredient(s), Dextromethorphan Hydrobromide; Guaifenesin. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021620
The FDA assigned number to Mucinex Dm. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mucinex Dm. 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 - Apr 29, 2004
The date Mucinex Dm 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 Mucinex Dm. 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 Dm 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 Dm.

Mucinex Dm