Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089474
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTAMINE SULFATE | PROTAMINE SULFATE | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/1986 | 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 |
|---|---|---|---|---|---|
| 06/29/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/30/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/28/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/26/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/14/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/17/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/28/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 11/06/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/08/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |