Dantrium

   
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Dantrium


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

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

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

Strength - 25MG
The potency of the active ingredient(s), Dantrolene Sodium. May repeat for multiple part products.

Applicant - PROCTER AND GAMBLE
The firm name holding legal responsibility for Dantrium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017443
The FDA assigned number to Dantrium. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Dantrium. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Dantrium 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 Dantrium. 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 Dantrium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Procter And Gamble Co
The full name of the firm holding legal responsibility for the new application of Dantrium.

Dantrium