Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022036
Company: CURRAX
Company: CURRAX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SILENOR | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
SILENOR | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
03/17/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022036s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036s000_silenor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022036Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022036Orig1s006ltr.pdf | |
12/22/2016 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/08/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/30/2011 | SUPPL-1 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022036s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/29/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf | |
03/17/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022036lbl.pdf |
SILENOR
TABLET;ORAL; EQ 3MG 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 3MG BASE | TABLET;ORAL | Prescription | No | AB | 201951 | ACTAVIS ELIZABETH |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 218564 | AJANTA PHARMA LTD |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 214823 | MSN |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 202337 | RK PHARMA |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 202510 | STRIDES PHARMA |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | No | AB | 202761 | ZYDUS LIFESCIENCES |
SILENOR | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022036 | CURRAX |
TABLET;ORAL; EQ 6MG 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 6MG BASE | TABLET;ORAL | Prescription | No | AB | 201951 | ACTAVIS ELIZABETH |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | No | AB | 218564 | AJANTA PHARMA LTD |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | No | AB | 214823 | MSN |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | No | AB | 202337 | RK PHARMA |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | No | AB | 202510 | STRIDES PHARMA |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | No | AB | 202761 | ZYDUS LIFESCIENCES |
SILENOR | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022036 | CURRAX |