Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019319
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | SOLUTION FOR SLUSH;IRRIGATION | Prescription | None | Yes | 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 |
---|---|---|---|---|---|---|---|
05/17/1985 | 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 |
---|---|---|---|---|---|
09/29/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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06/15/2007 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/14/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
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02/18/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/30/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/02/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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03/26/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/24/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/26/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |