SinoReg

Abbott B.V. — China registrations and re-registration filing lines

6 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2026-11-22.

Approval numberProductCertificate expiresFiling line (Art. 82)
国药准字HJ20171057Duphalac
乳果糖口服溶液
2027-05-222026-11-22
国药准字HJ20240082Estradiol and Dydrogesterone Tablets
雌二醇地屈孕酮片
2029-08-042029-02-04
国药准字HJ20150345Femoston
雌二醇片/雌二醇地屈孕酮片复合包装
2029-10-242029-04-24
国药准字HJ20150346Femoston
雌二醇片/雌二醇地屈孕酮片复合包装
2029-10-242029-04-24
国药准字HJ20170221Duphaston
地屈孕酮片
2031-02-012030-08-01
国药准字HJ20160345Duspatalin
盐酸美贝维林片
2031-03-262030-09-26

Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew an overseas-manufactured drug registration is filed with the Center for Drug Evaluation no later than 6 months before the certificate expires; the filing line column is that arithmetic applied to the expiry cell. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. Every figure is taken from the public NMPA database as of 2026-06-28, or computed from it. Registration data changes; the NMPA portal governs. This page states no view on whether any of these products' Domestic Responsible Person (境内责任人) arrangements meet NMPA Announcement No. 137 — that cannot be determined from a public entry.

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