Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090444
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE;ORAL Prescription AB No No
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE;ORAL Prescription AB No No
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE;ORAL Prescription AB No No
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE 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
04/16/2010 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
12/21/2014 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

IMIPRAMINE PAMOATE

CAPSULE;ORAL; EQ 75MG HYDROCHLORIDE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 090444 LUPIN LTD
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 091099 WEST-WARD PHARMS INT

CAPSULE;ORAL; EQ 100MG HYDROCHLORIDE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 090444 LUPIN LTD
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 091099 WEST-WARD PHARMS INT

CAPSULE;ORAL; EQ 125MG HYDROCHLORIDE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 090444 LUPIN LTD
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 091099 WEST-WARD PHARMS INT

CAPSULE;ORAL; EQ 150MG HYDROCHLORIDE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 090444 LUPIN LTD
IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE CAPSULE;ORAL Prescription No AB 091099 WEST-WARD PHARMS INT

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