Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062318
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 10MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 08/20/1981 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 12/04/1996 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/24/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/24/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/24/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/24/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/16/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |