# BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
> **ANDA205299** · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2018-06-14
## Drug
- **FDA Application Number:** ANDA205299
- **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:** DR REDDYS LABS SA
- **Manufacturer:** Dr.Reddys Laboratories Inc
- **First approval:** 2018-06-14
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205299)
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