Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081080
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/1991 | 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 |
|---|---|---|---|---|---|
| 01/09/2008 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/29/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/29/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/07/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/04/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/22/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/20/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 10/22/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |