Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085762
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 11/17/1977 | 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 |
|---|---|---|---|---|---|
| 11/30/2010 | SUPPL-62 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 04/15/1998 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1997 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/05/1995 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 12/29/1993 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1990 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/1987 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |