Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073685
Company: NOSTRUM LABS
Company: NOSTRUM LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACILAC | 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 |
|---|---|---|---|---|---|---|---|
| 05/28/1993 | 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 |
|---|---|---|---|---|---|
| 07/15/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/26/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/13/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/01/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/23/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |