Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207568
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPINEPHRINE | EPINEPHRINE | EQ 1MG BASE/ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 07/06/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207568Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/207568Orig1_Approval_Pkg.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/14/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |