Drugs@FDA: FDA-Approved Drugs

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

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

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