Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202337
Company: RK PHARMA
Company: RK PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 3MG BASE | TABLET;ORAL | Prescription | AB | No | No |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 6MG BASE | TABLET;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 |
---|---|---|---|---|---|---|---|
01/20/2016 | 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 |
---|---|---|---|---|---|
11/12/2021 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
DOXEPIN HYDROCHLORIDE
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 |