Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071548
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/15/1988 | 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 |
|---|---|---|---|---|---|
| 12/20/2009 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/07/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/16/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |