Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040218
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 75MG | TABLET;ORAL | Discontinued | None | No | No |
AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 150MG | 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 |
---|---|---|---|---|---|---|---|
09/11/1997 | 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 |
---|---|---|---|---|---|
04/25/2016 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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07/17/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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04/26/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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11/21/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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06/29/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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10/06/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
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08/03/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/26/2002 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |