Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089454
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTAMINE SULFATE | PROTAMINE SULFATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/07/1987 | 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 |
|---|---|---|---|---|---|
| 06/11/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/29/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/05/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/01/2002 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/23/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/27/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/22/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/25/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |