Coumadin

   
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Coumadin


Drug - Coumadin
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) - Warfarin Sodium
Multiple ingredients are in alphabetical order.

Strength - 4MG
The potency of the active ingredient(s), Warfarin Sodium. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Coumadin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 009218
The FDA assigned number to Coumadin. Format is nnnnnn.

Product Number - 023
The FDA assigned number to identify Coumadin. 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 - Aug 24, 1993
The date Coumadin 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 Coumadin. 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 Coumadin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Pharma Co
The full name of the firm holding legal responsibility for the new application of Coumadin.

Coumadin