Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088873
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENLON | EDROPHONIUM CHLORIDE | 10MG/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 |
|---|---|---|---|---|---|---|---|
| 08/06/1985 | 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 |
|---|---|---|---|---|---|
| 01/10/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 04/03/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/20/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/20/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/11/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/22/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/07/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |