Drugs@FDA: FDA-Approved Drugs

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

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

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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