Lungaggregate Reagent
Drug - Lungaggregate Reagent
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) -
Technetium Tc-99m Albumin Aggregated Kit
Multiple ingredients are in alphabetical order.
Strength -
N/A
The potency of the active ingredient(s), Technetium Tc-99m Albumin Aggregated Kit. May repeat for multiple part products.
Applicant -
GE HEALTHCARE
The firm name holding legal responsibility for Lungaggregate Reagent. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
017838
The FDA assigned number to Lungaggregate Reagent. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Lungaggregate Reagent. 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 Lungaggregate Reagent 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 Lungaggregate Reagent. 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 Lungaggregate Reagent is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Ge Healthcare
The full name of the firm holding legal responsibility for the new application of Lungaggregate Reagent.
Lungaggregate Reagent
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