Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087708
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | 0.025MG/5ML;2.5MG/5ML | SOLUTION;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/03/1982 | 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 |
|---|---|---|---|---|---|
| 05/05/2017 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/31/2008 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/16/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/28/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/28/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/20/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/12/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/27/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/23/1988 | SUPPL-1 | Bioequivalence |
Label is not available on this site. |