Belbuca FDA Approval History
FDA Approved: Yes (First approved October 23, 2015)
Brand name: Belbuca
Generic name: buprenorphine hydrochloride
Dosage form: Buccal Film
Company: Endo Pharmaceuticals Inc.
Treatment for: Chronic Pain
Belbuca (buprenorphine) is a partial opioid agonist analgesic in a buccal film formulation for the management of chronic pain.
Development Timeline for Belbuca
|Oct 26, 2015||FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management|
|Feb 23, 2015||Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for Belbuca (buprenorphine HCl) Buccal Film for Chronic Pain|
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