Dr. Reddy's Labs

RegulatoryAugust 19, 2026

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

The FDA has accepted the supplemental application ANDA205299 for Buprenorphine Hydrochloride and Naloxone Hydrochloride submitted by Dr. Reddy's Labs. This application is part of Dr.

Recent signals(11)

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

FDA grants AP status for Metformin Hydrochloride ANDA077787 by Dr. Reddy's Labs

FDA Approval Process for Nicotine Polacrilex by Dr. Reddy's Labs

FDA Accepts BLA761376 Application from Dr. Reddy's Labs

FDA Submission Overview for ANDA212336 by Dr. Reddy's Labs

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

FDA Accepts ANDA for Sitagliptin Phosphate by Dr. Reddy's Labs

FDA grants AP status for Phentermine Hydrochloride and Topiramate by Dr. Reddy's Labs

FDA Grants AP Status for Nicotine Polacrilex by Dr. Reddy's Labs

FDA Grants AP Status for Finasteride ANDA076437 by Dr. Reddy's Labs

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

Upcoming catalysts

Regulatory activity(6)

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

FDA Accepts BLA761376 Application from Dr. Reddy's Labs

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

FDA grants AP status for Phentermine Hydrochloride and Topiramate by Dr. Reddy's Labs

FDA Grants AP Status for Finasteride ANDA076437 by Dr. Reddy's Labs

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

Clinical activity

Competitive activity(3)

FDA Submission Overview for ANDA212336 by Dr. Reddy's Labs

FDA Accepts ANDA for Sitagliptin Phosphate by Dr. Reddy's Labs

FDA Grants AP Status for Nicotine Polacrilex by Dr. Reddy's Labs

Assets

Therapeutic areas

Indications

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