Stalevo 50

   
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Stalevo 50


Drug - Stalevo 50
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) - Carbidopa; Entacapone; Levodopa
Multiple ingredients are in alphabetical order.

Strength - 12.5MG;200MG;50MG
The potency of the active ingredient(s), Carbidopa; Entacapone; Levodopa. May repeat for multiple part products.

Applicant - ORION PHARMA INC
The firm name holding legal responsibility for Stalevo 50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021485
The FDA assigned number to Stalevo 50. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Stalevo 50. 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 - Jun 11, 2003
The date Stalevo 50 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 Stalevo 50. 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 Stalevo 50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Orion Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Stalevo 50.

Stalevo 50