Myfortic

   
Google
 
Web NewDrugInformation.com

Myfortic


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

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

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

Strength - 180MG
The potency of the active ingredient(s), Mycophenolic Acid. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050791
The FDA assigned number to Myfortic. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Myfortic. 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 - Feb 27, 2004
The date Myfortic 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 Myfortic. 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 Myfortic is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Myfortic.

Myfortic