Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089420
Company: SCHWARZ PHARMA
Company: SCHWARZ PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZDONE | ASPIRIN; HYDROCODONE BITARTRATE | 500MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 01/25/1988 | 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 |
|---|---|---|---|---|---|
| 09/14/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 06/22/1999 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 11/29/1999 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 02/23/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 02/23/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/30/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/30/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/22/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/16/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/06/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/15/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |