Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040889
Company: BRECKENRIDGE

Products on ANDA 040889

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040889

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040889

METHYLERGONOVINE MALEATE

INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHERGINE	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	006035	EDISON THERAPS LLC
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090193	AM REGENT
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040889	BRECKENRIDGE