Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072993
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 08/28/1992 | 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 |
|---|---|---|---|---|---|
| 11/03/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/2000 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/08/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/10/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |