Phosphocol P32

   
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Phosphocol P32


Drug - Phosphocol P32
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) - Chromic Phosphate, P-32
Multiple ingredients are in alphabetical order.

Strength - 5mCi/ML
The potency of the active ingredient(s), Chromic Phosphate, P-32. May repeat for multiple part products.

Applicant - MALLINCKRODT
The firm name holding legal responsibility for Phosphocol P32. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017084
The FDA assigned number to Phosphocol P32. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Phosphocol P32. 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 Phosphocol P32 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 Phosphocol P32. 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 Phosphocol P32 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 Phosphocol P32.

Phosphocol P32