Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071487
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/02/1987 | 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 |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/09/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/13/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/01/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/15/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/17/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/01/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |