# BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
> **ANDA212756** · Abbreviated New Drug Application (Generic) · Sponsor: DIFGEN PHARMS · Approved 2022-06-02
## Drug
- **FDA Application Number:** ANDA212756
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- **Generic name:** BUPRENORPHINE AND NALOXONE
- **Active ingredients:** BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- **Dosage form:** FILM
- **Route:** BUCCAL, SUBLINGUAL
- **Marketing status:** Prescription
- **Sponsor:** DIFGEN PHARMS
- **Manufacturer:** INGENUS PHARMACEUTICALS, LLC
- **First approval:** 2022-06-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212756)
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