Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074393
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOFLURANE | ISOFLURANE | 99.9% | LIQUID;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 05/12/1995 | 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-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 07/27/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/23/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/19/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 03/25/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |