Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208038
Company: US GENERICS, STERILES
Company: US GENERICS, STERILES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLNALTREXONE BROMIDE | METHYLNALTREXONE BROMIDE | 12MG/0.6ML | SOLUTION;SUBCUTANEOUS | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
08/12/2021 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208038Orig1s000TA_ltr.pdf |