Drugs@FDA: FDA-Approved Drugs
Company: PERRIGO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXYLAMINE SUCCINATE | DOXYLAMINE SUCCINATE | 25MG | TABLET;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
09/18/1996 | 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 |
---|---|---|---|---|---|
04/04/2024 | SUPPL-52 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/20/2024 | SUPPL-51 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/06/2023 | SUPPL-50 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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03/06/2015 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
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10/09/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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06/02/2009 | SUPPL-33 | Labeling |
Label is not available on this site. |
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07/14/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
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09/10/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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10/04/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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10/04/2001 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/10/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/10/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DOXYLAMINE SUCCINATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 25MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
DOXYLAMINE SUCCINATE | DOXYLAMINE SUCCINATE | 25MG | TABLET;ORAL | Over-the-counter | No | 040564 | LNK |
DOXYLAMINE SUCCINATE | DOXYLAMINE SUCCINATE | 25MG | TABLET;ORAL | Over-the-counter | No | 040167 | PERRIGO |
UNISOM | DOXYLAMINE SUCCINATE | 25MG | TABLET;ORAL | Over-the-counter | Yes | 018066 | CHATTEM |