Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086727
Company: ANI PHARMS
Company: ANI PHARMS
| 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;2.5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/29/1979 | 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 |
|---|---|---|---|---|---|
| 06/19/2007 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/29/2002 | SUPPL-38 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 09/12/2001 | SUPPL-36 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 08/15/2000 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 05/05/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 05/05/2000 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/2000 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/18/1999 | SUPPL-30 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/18/1999 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/18/1999 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 01/20/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/20/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |