Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062901
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/25/1988 | 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 |
|---|---|---|---|---|---|
| 05/01/2018 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/10/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/02/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 06/02/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/09/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/10/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/29/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/30/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/27/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 03/31/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |