Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 2,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 4,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 5,000 UNITS/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER | HEPARIN SODIUM | 10,000 UNITS/100ML | 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 |
---|---|---|---|---|---|---|---|
10/31/1983 | 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 |
---|---|---|---|---|---|
08/13/2010 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018814s032ltr.pdf | |
11/23/1999 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/19/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
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06/01/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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02/04/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
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09/17/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
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03/10/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/14/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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07/20/1994 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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07/20/1994 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/15/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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11/19/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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03/04/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/25/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/24/1989 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/19/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/08/1987 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/08/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/09/1985 | SUPPL-6 | Efficacy |
Label is not available on this site. |
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06/17/1985 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/31/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/16/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/08/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/13/2010 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf |