Drugs@FDA: FDA-Approved Drugs
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. |
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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. |