Prevalite

   
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Prevalite


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

Dosage - POWDER; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Cholestyramine
Multiple ingredients are in alphabetical order.

Strength - EQ 4GM RESIN/SCOOPFUL
The potency of the active ingredient(s), Cholestyramine. May repeat for multiple part products.

Applicant - UPSHER SMITH
The firm name holding legal responsibility for Prevalite. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073263
The FDA assigned number to Prevalite. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Prevalite. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Oct 30, 1997
The date Prevalite 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 Prevalite. 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 Prevalite is in. Format is RX, OTC, DISCN.

Applicant Full Name - Upsher Smith Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Prevalite.

Prevalite