Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017108
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WESTADONE | METHADONE HYDROCHLORIDE | 2.5MG | TABLET, DISPERSIBLE;ORAL | Discontinued | None | No | No |
| WESTADONE | METHADONE HYDROCHLORIDE | 5MG | TABLET, EFFERVESCENT;ORAL | Discontinued | None | No | No |
| WESTADONE | METHADONE HYDROCHLORIDE | 10MG | TABLET, EFFERVESCENT;ORAL | Discontinued | None | No | No |
| WESTADONE | METHADONE HYDROCHLORIDE | 40MG | TABLET, EFFERVESCENT;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 |
|---|---|---|---|---|---|---|---|
| 03/14/1973 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 12/12/1979 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/03/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/25/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 09/07/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |