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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203575
Company: ENDO OPERATIONS

REMS

Products on ANDA 203575

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2016	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203575Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2024	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
05/13/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/11/2021	SUPPL-7	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/21/2021	SUPPL-6	REMS - MODIFIED - D-N-A		Label is not available on this site.
01/15/2021	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/15/2021	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 203575

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELLCEPT	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050758	ROCHE PALO
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214283	BPI LABS
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203575	ENDO OPERATIONS
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212130	MEITHEAL
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203859	MYLAN LABS LTD
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204043	RISING
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216390	STERISCIENCE SPECLTS
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204473	ZYDUS PHARMS

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