Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 212624
Company: AJANTA PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 No
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
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 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
09/13/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

DOXEPIN HYDROCHLORIDE

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 207482 AMNEAL PHARMS CO
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 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

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 207482 AMNEAL PHARMS CO
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 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 25MG BASE CAPSULE;ORAL Prescription No AB 071437 PAR PHARM

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 207482 AMNEAL PHARMS CO
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 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

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 207482 AMNEAL PHARMS CO
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 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

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 207482 AMNEAL PHARMS CO
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 070791 MYLAN PHARMS INC
DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 071422 PAR PHARM

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