# BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
> **ANDA209069** · Abbreviated New Drug Application (Generic) · Sponsor: WES PHARMA INC · Approved 2020-07-17
## Drug
- **FDA Application Number:** ANDA209069
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- **Generic name:** BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
- **Active ingredients:** BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** SUBLINGUAL
- **Marketing status:** Prescription
- **Sponsor:** WES PHARMA INC
- **Manufacturer:** Accord Healthcare, Inc
- **First approval:** 2020-07-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209069)
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