Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091577
Company: CHARTWELL RX

Products on ANDA 091577

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091577

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091577s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/29/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091577

METHYLERGONOVINE MALEATE

TABLET;ORAL; 0.2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	No	AB	211483	AMNEAL PHARMS
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	No	AB	091577	CHARTWELL RX
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	No	AB	210424	GRANULES
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	No	AB	211919	RISING
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	No	AB	211455	TEVA PHARMS USA
METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET;ORAL	Prescription	No	AB	212233	TULEX PHARMS INC