Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076212
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 25MG;100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | 50MG;200MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
06/16/2004 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/17/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
12/30/2010 | SUPPL-9 | Labeling |
Label is not available on this site. |