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 25MG BASE | CAPSULE;ORAL | Prescription | AB | 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-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 06/25/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 01/30/2006 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/30/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 08/03/2005 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 07/07/2005 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 10/31/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/16/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/01/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
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| 11/21/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 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. |
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| 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. |
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| 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. |
||
| 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 25MG 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 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212624 | AJANTA PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215076 | ALEMBIC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207482 | AMNEAL PHARMS CO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214908 | APPCO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211603 | AUROBINDO PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210268 | CHARTWELL RX |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211619 | CHEMISTRY HLTH |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213474 | CONTRACT PHARMACAL |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210675 | EPIC PHARMA LLC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215483 | JUBILANT CADISTA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215710 | MANKIND PHARMA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217688 | MICRO LABS |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215113 | MSN |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070791 | MYLAN PHARMS INC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 071437 | PAR PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213063 | TARO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217975 | UNIQUE PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210700 | ZYDUS LIFESCIENCES |