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STALEVO 75 (nda021485)- (18.75MG;200MG;75MG)

CARBIDOPA; ENTACAPONE; LEVODOPA ORION PHARMA
18.75MG;200MG;75MG
Yes Yes
2020-Jun-29 Expired
None None
None No
Stalevo, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aromatic amino acid decarboxylation inhibitor), and entacapone (catechol-O-methyltransferase (COMT) inhibitor) is indicated for the treatment of Parkinson’s disease. Stalevo is to be used: • To substitute (with equivalent strengths of each of the three components) for carbidopa/levodopa and entacapone previously administered as individual products • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearingoff” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.
1 0 1
Total Other Developers None
Drugs with Suitability No
18.75MG;200MG;75MG ** ** - - 1
NDA Sales Available Total Generic Sales Available
No 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** ****** ***** *************** ******* *********** **** ***. *** ** ***, *** ************, **********, ********* ******, ***** (***) ***

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