Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070791
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | No | Yes |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|
| 05/13/1986 | 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 |
|---|---|---|---|---|---|
| 05/29/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/070791s027lbl.pdf | |
| 04/17/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/11/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/14/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/08/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/08/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/25/2000 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/19/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1986 | SUPPL-1 | Manufacturing (CMC) |
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-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/070791s027lbl.pdf |
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL; EQ 50MG 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 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212624 | AJANTA PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215076 | ALEMBIC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207482 | AMNEAL PHARMS CO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214908 | APPCO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211603 | AUROBINDO PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210268 | CHARTWELL RX |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211619 | CHEMISTRY HLTH |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213474 | CONTRACT PHARMACAL |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210675 | EPIC PHARMA LLC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215483 | JUBILANT CADISTA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215710 | MANKIND PHARMA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217688 | MICRO LABS |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215113 | MSN |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070791 | MYLAN PHARMS INC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213063 | TARO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217975 | UNIQUE PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210700 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; EQ 10MG 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 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212624 | AJANTA PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215076 | ALEMBIC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207482 | AMNEAL PHARMS CO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214908 | APPCO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211603 | AUROBINDO PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210268 | CHARTWELL RX |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211619 | CHEMISTRY HLTH |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213474 | CONTRACT PHARMACAL |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210675 | EPIC PHARMA LLC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215483 | JUBILANT CADISTA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215710 | MANKIND PHARMA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217688 | MICRO LABS |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215113 | MSN |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070791 | MYLAN PHARMS INC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213063 | TARO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217975 | UNIQUE PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210700 | ZYDUS LIFESCIENCES |
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 |
CAPSULE;ORAL; EQ 75MG 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 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212624 | AJANTA PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215076 | ALEMBIC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207482 | AMNEAL PHARMS CO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214908 | APPCO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211603 | AUROBINDO PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210268 | CHARTWELL RX |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211619 | CHEMISTRY HLTH |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213474 | CONTRACT PHARMACAL |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210675 | EPIC PHARMA LLC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215483 | JUBILANT CADISTA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215710 | MANKIND PHARMA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217688 | MICRO LABS |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215113 | MSN |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070791 | MYLAN PHARMS INC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213063 | TARO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217975 | UNIQUE PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210700 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; EQ 100MG 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 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212624 | AJANTA PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215076 | ALEMBIC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207482 | AMNEAL PHARMS CO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 214908 | APPCO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211603 | AUROBINDO PHARMA LTD |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210268 | CHARTWELL RX |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 211619 | CHEMISTRY HLTH |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213474 | CONTRACT PHARMACAL |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210675 | EPIC PHARMA LLC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215483 | JUBILANT CADISTA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215710 | MANKIND PHARMA |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217688 | MICRO LABS |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215113 | MSN |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 070791 | MYLAN PHARMS INC |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213063 | TARO |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 217975 | UNIQUE PHARM |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210700 | ZYDUS LIFESCIENCES |