Drugs@FDA: FDA-Approved Drugs
Company: PHARM ASSOC
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 |
---|---|---|---|---|---|---|---|
12/22/1988 | 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 |
---|---|---|---|---|---|
12/15/2023 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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06/28/2018 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2018 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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08/29/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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08/29/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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01/13/2017 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/10/2013 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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01/21/2010 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/23/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/19/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/17/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |