Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205071
Company: BRECKENRIDGE

Products on ANDA 205071

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 205071

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2016	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
04/14/2026	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/14/2026	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/14/2026	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205071

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
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
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
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
SAVELLA	MILNACIPRAN HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	Yes	AB	022256	ABBVIE