Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211618
Company: LEADING
Company: LEADING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG 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 |
---|---|---|---|---|---|---|---|
03/01/2021 | ORIG-1 | Approval | STANDARD |
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 |