Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018792
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOPHAM 6.4% | AMINO ACIDS | 6.4% (6.4GM/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 |
|---|---|---|---|---|---|---|---|
| 01/17/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 02/09/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/10/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/11/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1986 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/27/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |