Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 020360
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HEPATASOL 8% | AMINO ACIDS | 8% (8GM/100ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/04/1996 | 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 |
|---|---|---|---|---|---|
| 09/08/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/11/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |