Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218566
Company: CONCORD BIOTECH LTD

Products on ANDA 218566

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218566

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218566

MYCOPHENOLATE MOFETIL

FOR SUSPENSION;ORAL; 200MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELLCEPT	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	050759	ROCHE PALO
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	203005	ALKEM LABS LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	214871	AMNEAL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	218227	AUROBINDO PHARMA LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	218566	CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	214525	LANNETT CO INC
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213955	RISING
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	212634	STRIDES PHARMA INTL
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210370	VISTAPHARM LLC