Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090193
Company: AM REGENT
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 |