Drugs@FDA: FDA-Approved Drugs
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
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-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 01/30/2006 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/30/2005 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/03/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/07/2005 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 11/26/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/25/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/09/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/03/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/15/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/30/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/30/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213796 | EDENBRIDGE PHARMS |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211618 | LEADING |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071422 | PAR PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210140 | ZYDUS LIFESCIENCES |