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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, 2015Approval FDA Approves Belbuca (buprenorphine) Buccal Film for Chronic Pain Management
Feb 23, 2015Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for Belbuca (buprenorphine HCl) Buccal Film for Chronic Pain

Further information

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