Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IRRIGATING SOLUTION G IN PLASTIC CONTAINER | CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE | 3.24GM/100ML;380MG/100ML;430MG/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 |
---|---|---|---|---|---|---|---|
06/22/1982 | 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 |
---|---|---|---|---|---|
03/30/2001 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
07/17/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18519slr014ltr.pdf |
09/14/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/30/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/24/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/26/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/14/1991 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/26/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/30/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/06/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
02/28/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |