Adagen
Drug - Adagen
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) -
Pegademase Bovine
Multiple ingredients are in alphabetical order.
Strength -
250 UNITS/ML
The potency of the active ingredient(s), Pegademase Bovine. May repeat for multiple part products.
Applicant -
ENZON
The firm name holding legal responsibility for Adagen. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019818
The FDA assigned number to Adagen. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Adagen. 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 -
Mar 21, 1990
The date Adagen 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 Adagen. 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 Adagen is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Enzon Inc
The full name of the firm holding legal responsibility for the new application of Adagen.
Adagen
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