Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075880
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREMASOL 10% IN PLASTIC CONTAINER | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| PREMASOL 6% IN PLASTIC CONTAINER | AMINO ACIDS | 6% (6GM/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 |
|---|---|---|---|---|---|---|---|
| 06/19/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/06/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/23/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |