Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073254
Company: CONTRACT PHARMACAL
Company: CONTRACT PHARMACAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1993 | 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 |
|---|---|---|---|---|---|
| 09/21/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/16/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/26/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/30/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/25/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/27/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |