Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090193
Company: AM REGENT

Products on ANDA 090193

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 090193

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/2008	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/090193s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090193s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090193

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/090193s000lbl.pdf

Therapeutic Equivalents for ANDA 090193

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