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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208895
Company: SANDOZ INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBIDOPA; LEVODOPA CARBIDOPA;LEVODOPA 23.75MG;95MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
CARBIDOPA; LEVODOPA CARBIDOPA;LEVODOPA 36.25MG;145MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
CARBIDOPA; LEVODOPA CARBIDOPA;LEVODOPA 48.75MG;195MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
CARBIDOPA; LEVODOPA CARBIDOPA;LEVODOPA 61.25MG;245MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/31/2023 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208895Orig1s000TA_ltr.pdf
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