Opioid Dependence

RegulatoryAugust 19, 2026

FDA Approval Status for Buprenorphine and Naloxone Hydrochloride by Difgen Pharms

The FDA has granted an approval status (AP) for ANDA212756, a supplemental application for Buprenorphine Hydrochloride and Naloxone Hydrochloride submitted by Difgen Pharms.

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Recent signals(8)

FDA Approval Status for Buprenorphine and Naloxone Hydrochloride by Difgen Pharms

FDA Accepts Supplement for Buprenorphine/Naloxone from Ascent Pharmaceuticals

FDA Acceptance of Supplement for Buprenorphine/Naloxone by Ascent Pharms

FDA Acceptance of Supplement for Buprenorphine/Naloxone by Dr. Reddy's Labs

FDA Acceptance of Supplemental NDA for Suboxone by Indivior

FDA Acceptance of Supplement for ZUBSOLV by Edenbridge Pharmaceuticals

FDA Accepts Supplement for Buprenorphine and Naloxone from Dr. Reddy's Labs

FDA Approval Update for Buprenorphine and Naloxone from Dr. Reddy's Labs

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