Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 020512
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER | AMINO ACIDS | 15% (15GM/100ML) | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 08/30/1996 | 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 |
|---|---|---|---|---|---|
| 12/04/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/30/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |