Novothyrox

   
Google
 
Web NewDrugInformation.com

Novothyrox


Drug - Novothyrox
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) - Levothyroxine Sodium
Multiple ingredients are in alphabetical order.

Strength - 0.137MG **See Current Cumulative Supplement 1.3
The potency of the active ingredient(s), Levothyroxine Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021292
The FDA assigned number to Novothyrox. Format is nnnnnn.

Product Number - 008
The FDA assigned number to identify Novothyrox. 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 - May 31, 2002
The date Novothyrox 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 Novothyrox. 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 Novothyrox is in. Format is RX, OTC, DISCN.

Applicant Full Name - Genpharm Inc
The full name of the firm holding legal responsibility for the new application of Novothyrox.

Novothyrox