Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210370
Company: VISTAPHARM

• REMS

Products on ANDA 210370

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 210370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2022	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/10/2022	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2021	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/21/2021	SUPPL-8	REMS - MODIFIED - D-N-A		Label is not available on this site.
01/15/2021	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
11/10/2022	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/25/2019	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210370

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	213955	HETERO LABS LTD V
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	212634	STRIDES PHARMA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211272	TEVA PHARMS USA
MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	200MG/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210370	VISTAPHARM