Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072278
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 25MG BASE;10MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/09/1988 | 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 |
|---|---|---|---|---|---|
| 06/24/2025 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 01/17/2023 | SUPPL-15 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 02/05/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/25/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/17/2014 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/22/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/30/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 12/13/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/23/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/08/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |