Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087324
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOETHARINE HYDROCHLORIDE | ISOETHARINE HYDROCHLORIDE | 0.2% | 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 |
|---|---|---|---|---|---|---|---|
| 04/08/1981 | 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 |
|---|---|---|---|---|---|
| 08/28/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 10/12/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 01/27/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/16/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/17/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 11/14/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/14/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1988 | SUPPL-5 | Bioequivalence |
Label is not available on this site. |
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| 01/14/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |