Athrombin
Drug - Athrombin
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 -
10MG
The potency of the active ingredient(s), Warfarin Sodium. May repeat for multiple part products.
Applicant -
PURDUE FREDERICK
The firm name holding legal responsibility for Athrombin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
011771
The FDA assigned number to Athrombin. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Athrombin. 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 -
Approved Prior to Jan 1, 1982
The date Athrombin 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 Athrombin. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Athrombin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Purdue Frederick Co
The full name of the firm holding legal responsibility for the new application of Athrombin.
Athrombin
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