Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080269
Company: PAR PHARM
Company: PAR PHARM
| 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 |
|---|---|---|---|---|---|---|---|
| 11/30/1971 | 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 |
|---|---|---|---|---|---|
| 07/29/2002 | SUPPL-109 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-108 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 09/21/2000 | SUPPL-107 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/2000 | SUPPL-106 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-105 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-104 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/23/1999 | SUPPL-103 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/20/1999 | SUPPL-102 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1998 | SUPPL-101 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-100 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1992 | SUPPL-98 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/04/1992 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1992 | SUPPL-96 | Labeling |
Label is not available on this site. |
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| 06/11/1987 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1987 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1987 | SUPPL-92 | Manufacturing (CMC) |
Label is not available on this site. |