Indiclor

   
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Indiclor


Drug - Indiclor
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) - Indium In 111 Chloride
Multiple ingredients are in alphabetical order.

Strength - 2mCi/0.2ML
The potency of the active ingredient(s), Indium In 111 Chloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019862
The FDA assigned number to Indiclor. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Indiclor. 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 29, 1992
The date Indiclor 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 Indiclor. 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 Indiclor is in. Format is RX, OTC, DISCN.

Applicant Full Name - Amersham Corp Sub Radiochemical Center
The full name of the firm holding legal responsibility for the new application of Indiclor.

Indiclor