美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=BUPRENORPHINE HYDROCHLORIDE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
BUPRENORPHINE HYDROCHLORIDE 201066 002 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE No No 2015/03/06 2015/03/06 NORVIUM BIOSCIENCE Discontinued
BUPRENORPHINE HYDROCHLORIDE 090279 001 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE No No 2015/06/10 2015/06/10 RUBICON Prescription
BUPRENORPHINE HYDROCHLORIDE 090279 002 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE No No 2015/06/10 2015/06/10 RUBICON Prescription
BUPRENORPHINE HYDROCHLORIDE 206586 001 ANDA BUPRENORPHINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 0.3MG BASE/ML No Yes 2015/07/28 2015/07/28 ENDO OPERATIONS Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 204431 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No 2015/10/16 2015/10/16 ETHYPHARM USA CORP Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 204431 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2015/10/16 2015/10/16 ETHYPHARM USA CORP Prescription
BUPRENORPHINE HYDROCHLORIDE 201760 001 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE No No 2016/01/29 2016/01/29 SUN PHARM Prescription
BUPRENORPHINE HYDROCHLORIDE 201760 002 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE No No 2016/01/29 2016/01/29 SUN PHARM Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 201633 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No 2016/08/05 2016/08/05 SUN PHARM Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 201633 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2016/08/05 2016/08/05 SUN PHARM Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 205022 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No 2016/09/19 2016/09/19 LANNETT CO INC Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 205022 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2016/09/19 2016/09/19 LANNETT CO INC Prescription
BUPRENORPHINE HYDROCHLORIDE 207276 001 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE No No 2017/03/27 2017/03/27 RHODES PHARMS Prescription
BUPRENORPHINE HYDROCHLORIDE 207276 002 ANDA BUPRENORPHINE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE No No 2017/03/27 2017/03/27 RHODES PHARMS Prescription
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 204383 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2017/10/24 (TA) -- ACTAVIS LABS UT INC None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 207000 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No 2017/12/13 2017/12/13 SPECGX LLC Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 207000 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2017/12/13 2017/12/13 SPECGX LLC Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 205299 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No 2018/06/14 2018/06/14 DR REDDYS LABS SA Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 205299 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2018/06/14 2018/06/14 DR REDDYS LABS SA Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 205806 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE No No 2018/06/14 2018/06/14 DR REDDYS LABS SA Prescription
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