# DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
> **ANDA213413** · Abbreviated New Drug Application (Generic) · Sponsor: LEADING · Approved 2020-02-20
## Drug
- **FDA Application Number:** ANDA213413
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- **Generic name:** DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- **Active ingredients:** ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** LEADING
- **Manufacturer:** Leading Pharma, LLC
- **First approval:** 2020-02-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213413)
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