Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210911
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | UNKNOWN | UNKNOWN | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 36.25MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 145MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 23.75MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 95MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 245MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 61.25MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 48.75MG | CAPSULE, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| CARBIDOPA; LEODOPA | CARBIDOPA;LEODOPA | 195MG | CAPSULE, EXTENDED RELEASE | 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 |
|---|---|---|---|---|---|---|---|
| 08/08/2025 | ORIG-2 | Tentative Approval | UNKNOWN |
Label is not available on this site. |
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| 08/08/2025 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210911Orig1s000TAltr.pdf |