Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019678
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENLON-PLUS | ATROPINE SULFATE; EDROPHONIUM CHLORIDE | 0.14MG/ML;10MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/28/2025 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019678Orig1s010lbl.pdf | |
| 10/28/2025 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019678Orig1s010lbl.pdf | |
| 12/06/2005 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf |