Megatope

   
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Megatope


Drug - Megatope
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-131 Serum
Multiple ingredients are in alphabetical order.

Strength - 20uCi/AMP
The potency of the active ingredient(s), Albumin Iodinated I-131 Serum. May repeat for multiple part products.

Applicant - ISO TEX
The firm name holding legal responsibility for Megatope. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017837
The FDA assigned number to Megatope. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Megatope. 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 Megatope 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 Megatope. 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 Megatope is in. Format is RX, OTC, DISCN.

Applicant Full Name - Iso Tex Diagnostics Inc
The full name of the firm holding legal responsibility for the new application of Megatope.

Megatope