# SCOPOLAMINE
> **ANDA218384** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2025-06-09
## Drug
- **FDA Application Number:** ANDA218384
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SCOPOLAMINE
- **Generic name:** SCOPOLAMINE
- **Active ingredients:** SCOPOLAMINE
- **Dosage form:** SYSTEM
- **Route:** TRANSDERMAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **Manufacturer:** Amneal Pharmaceuticals NY LLC
- **First approval:** 2025-06-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218384)
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