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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091558
Company: APOTEX INC

REMS

Products on ANDA 091558

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091558

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/2014	ORIG-2	Approval				Label is not available on this site.
08/21/2012	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
08/13/2024	SUPPL-22	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/28/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/11/2021	SUPPL-18	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/28/2023	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/21/2021	SUPPL-16	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/28/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
01/15/2021	SUPPL-12	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/31/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/13/2015	SUPPL-6	REMS-Modified		Label is not available on this site.
06/26/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/30/2013	SUPPL-2	REMS-Modified		Label is not available on this site.
09/25/2012	SUPPL-1	REMS-Proposal		Label is not available on this site.

Therapeutic Equivalents for ANDA 091558

MYCOPHENOLATE SODIUM

TABLET, DELAYED RELEASE;ORAL; EQ 180MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202555	ACCORD HLTHCARE
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	208315	ALKEM LABS LTD
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091558	APOTEX INC
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	218603	AUROBINDO PHARMA LTD
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214630	BIOCON PHARMA
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217031	BIOCON PHARMA
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211173	CONCORD BIOTECH LTD
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216637	FOSUN WANBANG
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214376	YICHANG HUMANWELL
MYFORTIC	MYCOPHENOLATE SODIUM	EQ 180MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	050791	NOVARTIS

TABLET, DELAYED RELEASE;ORAL; EQ 360MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202555	ACCORD HLTHCARE
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	208315	ALKEM LABS LTD
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091558	APOTEX INC
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	218603	AUROBINDO PHARMA LTD
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214630	BIOCON PHARMA
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217031	BIOCON PHARMA
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211173	CONCORD BIOTECH LTD
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216637	FOSUN WANBANG
MYCOPHENOLATE SODIUM	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214376	YICHANG HUMANWELL
MYFORTIC	MYCOPHENOLATE SODIUM	EQ 360MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	050791	NOVARTIS

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