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Drug - Octreoscan
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Indium In-111 Pentetreotide Kit
Multiple ingredients are in alphabetical order.

Strength - 3mCi/ML
The potency of the active ingredient(s), Indium In-111 Pentetreotide Kit. May repeat for multiple part products.

The firm name holding legal responsibility for Octreoscan. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020314
The FDA assigned number to Octreoscan. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Octreoscan. 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 - Jun 2, 1994
The date Octreoscan 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 Octreoscan. 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 Octreoscan is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mallinckrodt Medical Inc
The full name of the firm holding legal responsibility for the new application of Octreoscan.