Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204797
Company: EXELA PHARMA
Company: EXELA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETYLCYSTEINE | ACETYLCYSTEINE | 6GM/30ML (200MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | 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 |
---|---|---|---|---|---|---|---|
04/15/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |