Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208895
Company: SANDOZ INC
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 |