Manages pain severe enough to require an opioid analgesic. ANDA 221145, held by Gland. Buprenorphine Hydrochloride.
As of Nov 15, 2026, ANDA 221145 (Buprenorphine Hydrochloride), held by Gland, was first approved by FDA on Oct 15, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including buprenorphine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Buprenorphine HydrochlorideEQ 0.3MG BASE/ML · injectable;injection | Buprenorphine Hydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
