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

The product dosage form and route separated by a semi-colon.

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

Strength - 0.05MG **See Current Cumulative Supplement 1.3
The potency of the active ingredient(s), Levothyroxine Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021137
The FDA assigned number to Levolet. Format is nnnnnn.

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

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

Approval Date - Jun 6, 2003
The date Levolet 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 Levolet. 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 Levolet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Vintage Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Levolet.