Drugs@FDA: FDA-Approved Drugs
Company: TEVA PHARMS
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 |
---|---|---|---|---|---|---|---|
11/09/1987 | 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-28 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071609s028lbl.pdf | |
10/29/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
07/09/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
05/23/2006 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/08/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
03/13/2002 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
02/27/2002 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
02/27/2002 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
10/31/2001 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/31/2001 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/31/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/23/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
02/26/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/17/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/23/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/13/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/12/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
05/27/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/29/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/29/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/17/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071609s028lbl.pdf |