Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071918
Company: PHARMOBEDIENT CNSLTG
Company: PHARMOBEDIENT CNSLTG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 07/20/1988 | 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 |
|---|---|---|---|---|---|
| 07/17/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/13/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 06/26/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 11/05/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/11/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/17/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/17/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 11/24/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/12/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/02/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |