Tolectin 600

   
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Tolectin 600


Drug - Tolectin 600
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) - Tolmetin Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 600MG BASE
The potency of the active ingredient(s), Tolmetin Sodium. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Tolectin 600. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017628
The FDA assigned number to Tolectin 600. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Tolectin 600. 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 - Mar 8, 1989
The date Tolectin 600 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 Tolectin 600. 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 Tolectin 600 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ortho Mcneil Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Tolectin 600.

Tolectin 600