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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210944
Company: MACLEODS PHARMS

Products on ANDA 210944

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	AB	No	No
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	AB	No	No
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210944

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210944Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 210944

MILNACIPRAN HYDROCHLORIDE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	205081	AMNEAL PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	205071	BRECKENRIDGE
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	205147	HETERO LABS LTD V
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	210944	MACLEODS PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	207399	STRIDES PHARMA
SAVELLA	MILNACIPRAN HYDROCHLORIDE	12.5MG	TABLET;ORAL	Prescription	Yes	AB	022256	ABBVIE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	205081	AMNEAL PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	205071	BRECKENRIDGE
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	205147	HETERO LABS LTD V
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	210944	MACLEODS PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AB	207399	STRIDES PHARMA
SAVELLA	MILNACIPRAN HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	Yes	AB	022256	ABBVIE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	205081	AMNEAL PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	205071	BRECKENRIDGE
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	205147	HETERO LABS LTD V
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	210944	MACLEODS PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	207399	STRIDES PHARMA
SAVELLA	MILNACIPRAN HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	022256	ABBVIE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	205081	AMNEAL PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	205071	BRECKENRIDGE
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	205147	HETERO LABS LTD V
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	210944	MACLEODS PHARMS
MILNACIPRAN HYDROCHLORIDE	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207399	STRIDES PHARMA
SAVELLA	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	Yes	AB	022256	ABBVIE

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