Tham
Drug - Tham
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Tromethamine
Multiple ingredients are in alphabetical order.
Strength -
3.6GM/100ML
The potency of the active ingredient(s), Tromethamine. May repeat for multiple part products.
Applicant -
HOSPIRA
The firm name holding legal responsibility for Tham. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
013025
The FDA assigned number to Tham. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Tham. 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 Tham 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 Tham. 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 Tham is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hospira Inc
The full name of the firm holding legal responsibility for the new application of Tham.
Tham
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