Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018911
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 10,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% | HEPARIN SODIUM | 100 UNITS/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 |
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01/30/1985 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/24/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/27/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/24/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/29/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/24/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/14/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/24/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/29/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |