Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062816
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMPICILLIN SODIUM | AMPICILLIN SODIUM | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 10/28/1988 | 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 |
|---|---|---|---|---|---|
| 12/08/2000 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/29/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/17/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/23/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/19/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/09/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/09/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/26/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/23/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/10/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/08/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |