Drugs@FDA: FDA-Approved Drugs
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LARODOPA | LEVODOPA | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LARODOPA | LEVODOPA | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LARODOPA | LEVODOPA | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| LARODOPA | LEVODOPA | 500MG | TABLET;ORAL | Discontinued | None | No | No |
| LARODOPA | LEVODOPA | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| LARODOPA | LEVODOPA | 500MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/04/1970 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/19/1998 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/05/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/03/1997 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/08/1993 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/03/1986 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 12/19/1983 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/17/1983 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/12/1980 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1980 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/13/1979 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/05/1977 | SUPPL-34 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/26/1977 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 05/02/1977 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 04/29/1977 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/27/1978 | SUPPL-30 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 01/14/1977 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/14/1977 | SUPPL-28 | Unspecified |
Label is not available on this site. |
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| 08/22/1975 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/06/1975 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/08/1974 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 08/02/1974 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/02/1974 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |