Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086899
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOETHARINE HYDROCHLORIDE | ISOETHARINE HYDROCHLORIDE | 1% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 10/23/1979 | 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 |
|---|---|---|---|---|---|
| 11/25/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/23/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 09/15/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/20/1989 | SUPPL-3 | Bioequivalence |
Label is not available on this site. |
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| 09/10/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/10/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |