Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217828
Company: AUROBINDO PHARMA LTD

Products on ANDA 217828

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217828

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217828

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CELLCEPT	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	Yes	AB	050722	ROCHE PALO
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	090253	ACCORD HLTHCARE
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	200197	ALKEM LABS LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	217828	AUROBINDO PHARMA LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	210181	CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	065410	HIKMA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	065520	MYLAN
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	065379	SANDOZ
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	090055	STRIDES PHARMA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	065491	TEVA PHARMS
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE;ORAL	Prescription	No	AB	204077	ZHEJIANG HISUN PHARM