Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074906
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACYCLOVIR | ACYCLOVIR | 200MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/26/1997 | 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 |
|---|---|---|---|---|---|
| 10/28/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/23/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/02/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 03/26/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |