Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019933
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | SOLUTION;IRRIGATION | 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1989 | 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 |
|---|---|---|---|---|---|
| 06/15/2007 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 08/14/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/18/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/30/1994 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/05/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/26/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |