Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040151
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 08/26/1997 | 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 |
|---|---|---|---|---|---|
| 10/09/2009 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/22/2025 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/15/2023 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2018 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2018 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-18 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/13/2017 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2009 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/25/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/04/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 02/17/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |