Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074720
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR SODIUM | ACYCLOVIR SODIUM | EQ 25MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1997 | 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 |
|---|---|---|---|---|---|
| 09/30/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/10/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 11/27/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/21/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/29/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-3 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |