Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071050
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ASTRAMORPH PF | MORPHINE SULFATE | 0.5MG/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 |
|---|---|---|---|---|---|---|---|
| 10/07/1986 | 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 |
|---|---|---|---|---|---|
| 10/21/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/30/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/02/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/12/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/02/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/20/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/20/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/20/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |