Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072058
Company: ELKINS SINN
Company: ELKINS SINN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PANCURONIUM BROMIDE | PANCURONIUM BROMIDE | 1MG/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 |
|---|---|---|---|---|---|---|---|
| 03/23/1988 | 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 |
|---|---|---|---|---|---|
| 09/10/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-12 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/22/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/17/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |