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 211594 002 ANDA BUPRENORPHINE HYDROCHLORIDE FILM;BUCCAL EQ 0.15MG BASE No No 2021/08/03 2021/08/03 ALVOGEN Discontinued
BUPRENORPHINE HYDROCHLORIDE 211594 003 ANDA BUPRENORPHINE HYDROCHLORIDE FILM;BUCCAL EQ 0.3MG BASE No No 2021/08/03 2021/08/03 ALVOGEN Discontinued
BUPRENORPHINE HYDROCHLORIDE 211594 004 ANDA BUPRENORPHINE HYDROCHLORIDE FILM;BUCCAL EQ 0.45MG BASE No No 2021/08/03 2021/08/03 ALVOGEN Discontinued
BUPRENORPHINE HYDROCHLORIDE 211594 005 ANDA BUPRENORPHINE HYDROCHLORIDE FILM;BUCCAL EQ 0.6MG BASE No No 2021/08/03 2021/08/03 ALVOGEN Discontinued
BUPRENORPHINE HYDROCHLORIDE 211594 006 ANDA BUPRENORPHINE HYDROCHLORIDE FILM;BUCCAL EQ 0.75MG BASE No No 2021/08/03 2021/08/03 ALVOGEN Discontinued
BUPRENORPHINE HYDROCHLORIDE 211594 007 ANDA BUPRENORPHINE HYDROCHLORIDE FILM;BUCCAL EQ 0.9MG BASE No No 2021/08/03 2021/08/03 ALVOGEN Discontinued
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 212756 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No 2022/06/02 2022/06/02 AVEVA Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 212756 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE No No 2022/06/02 2022/06/02 AVEVA Prescription
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 214737 001 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 1.4MG BASE;EQ 0.36MG BASE No No 2023/08/11 (TA) -- SUN PHARM INDUSTRIES None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 214737 002 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 5.7MG BASE;EQ 1.4MG BASE No No 2023/08/11 (TA) -- SUN PHARM INDUSTRIES None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 214737 003 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8.6MG BASE;EQ 2.1MG BASE No No 2023/08/11 (TA) -- SUN PHARM INDUSTRIES None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 214737 004 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 11.4MG BASE;EQ 2.9MG BASE No No 2023/08/11 (TA) -- SUN PHARM INDUSTRIES None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 214737 005 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2.9MG BASE;EQ 0.71MG BASE No No 2023/08/11 (TA) -- SUN PHARM INDUSTRIES None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 214737 006 ANDA BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 0.7MG BASE;EQ 0.18MG BASE No No 2023/08/11 (TA) -- SUN PHARM INDUSTRIES None (Tentative Approval)
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