Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072277
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 12.5MG BASE;5MG | 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 |
---|---|---|---|---|---|
01/17/2023 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
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. |