Rezulin

   
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Rezulin


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

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

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

Strength - 200MG
The potency of the active ingredient(s), Troglitazone. May repeat for multiple part products.

Applicant - PFIZER PHARMS
The firm name holding legal responsibility for Rezulin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020720
The FDA assigned number to Rezulin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Rezulin. 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 - Jan 29, 1997
The date Rezulin 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 Rezulin. 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 Rezulin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Pharmaceuticals Ltd
The full name of the firm holding legal responsibility for the new application of Rezulin.

Rezulin