Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083125
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPOXYPHENE HYDROCHLORIDE | PROPOXYPHENE HYDROCHLORIDE | 65MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/18/1972 | 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 |
|---|---|---|---|---|---|
| 10/14/1998 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1990 | SUPPL-78 | Labeling |
Label is not available on this site. |
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| 01/06/1989 | SUPPL-77 | Labeling |
Label is not available on this site. |
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| 01/15/1988 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1988 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1987 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1987 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1987 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/15/1984 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/15/1984 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1983 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1983 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1983 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/09/1982 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1982 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1982 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/09/1982 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/10/1982 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |