Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211483
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
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 | 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 |
---|---|---|---|---|---|---|---|
09/10/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211483Orig1s000ltr.pdf |
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 PHARMA |
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 |