Sandimmune

   
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Sandimmune


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

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

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

Strength - 100MG/ML
The potency of the active ingredient(s), Cyclosporine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050574
The FDA assigned number to Sandimmune. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Sandimmune. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB2
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Nov 14, 1983
The date Sandimmune 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 Sandimmune. 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 Sandimmune 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 Sandimmune.

Sandimmune