Spectamine

   
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Spectamine


Drug - Spectamine
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) - Iofetamine Hydrochloride I-123
Multiple ingredients are in alphabetical order.

Strength - 1mCi/ML
The potency of the active ingredient(s), Iofetamine Hydrochloride I-123. May repeat for multiple part products.

Applicant - IMP
The firm name holding legal responsibility for Spectamine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019432
The FDA assigned number to Spectamine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Spectamine. 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 - Dec 24, 1987
The date Spectamine 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 Spectamine. 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 Spectamine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Imp Inc
The full name of the firm holding legal responsibility for the new application of Spectamine.

Spectamine