Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016913
Company: SHIRE
Company: SHIRE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOPAR | LEVODOPA | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| DOPAR | LEVODOPA | 500MG | CAPSULE;ORAL | Discontinued | None | No | No |
| DOPAR | LEVODOPA | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
| DOPAR | LEVODOPA | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| DOPAR | LEVODOPA | 500MG | TABLET;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 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/05/1992 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/29/1989 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/23/1986 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1983 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1983 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1983 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1983 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/30/1983 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/22/1977 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/14/1977 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 07/30/1976 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/27/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/27/1975 | SUPPL-15 | Efficacy |
Label is not available on this site. |