Pyrolite

   
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Pyrolite


Drug - Pyrolite
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) - Technetium Tc-99m Pyro/trimeta Phosphates Kit
Multiple ingredients are in alphabetical order.

Strength - N/A
The potency of the active ingredient(s), Technetium Tc-99m Pyro/trimeta Phosphates Kit. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 017684
The FDA assigned number to Pyrolite. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pyrolite. 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 Pyrolite 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 Pyrolite. 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 Pyrolite is in. Format is RX, OTC, DISCN.

Applicant Full Name - Cis Us Inc
The full name of the firm holding legal responsibility for the new application of Pyrolite.

Pyrolite