Cyclosporine

   
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Cyclosporine


Drug - Cyclosporine
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 - MORTON GROVE
The firm name holding legal responsibility for Cyclosporine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065133
The FDA assigned number to Cyclosporine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cyclosporine. 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 - Sep 17, 2004
The date Cyclosporine 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 Cyclosporine. 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 Cyclosporine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Morton Grove Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Cyclosporine.

Cyclosporine