Radio-iodinated (i 125) Serum Albumin (human)

   
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Radio-iodinated (i 125) Serum Albumin (human)


Drug - Radio-iodinated (i 125) Serum Albumin (human)
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) - Albumin Iodinated I-125 Serum
Multiple ingredients are in alphabetical order.

Strength - 2.5uCi/AMP
The potency of the active ingredient(s), Albumin Iodinated I-125 Serum. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Radio-iodinated (i 125) Serum Albumin (human). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017846
The FDA assigned number to Radio-iodinated (i 125) Serum Albumin (human). Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Radio-iodinated (i 125) Serum Albumin (human). 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 Radio-iodinated (i 125) Serum Albumin (human) 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 Radio-iodinated (i 125) Serum Albumin (human). 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 Radio-iodinated (i 125) Serum Albumin (human) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Radio-iodinated (i 125) Serum Albumin (human).

Radio-iodinated (i 125) Serum Albumin (human)