Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089624
Company: ORGANON USA INC
Company: ORGANON USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REVERSOL | 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 |
|---|---|---|---|---|---|---|---|
| 05/13/1988 | 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 |
|---|---|---|---|---|---|
| 06/09/1999 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/23/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/04/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 05/08/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/06/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |