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Buprenorphine HCl and Naloxone HCl - Buprenorphine and Naloxone

Navigation: NDC > Supplier starting with: A > AMNEAL PHARMACEUTICALS, LLC
Field Value
NDC Code: 65162-415
Proprietary Name: Buprenorphine HCl and Naloxone HCl
Suffix:
Non-Proprietary Name: Buprenorphine and Naloxone
Dosage Form: TABLET
Method: SUBLINGUAL
Original Marketing Date: 22-02-2013
Category Name: ANDA
Application Number: ANDA203136
Labeler: AMNEAL PHARMACEUTICALS, LLC
Substance Name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Numerator Strength: 8; 2
Active Ingredient Unit: mg/1; mg/1
Pharm Classes: Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA Schedule: CIII