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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
28/03/2025 Pfizer Inc
U.S.A
PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC 13407 SPECTINOMYCIN HYDROCHLORIDE 1998-09-01 Inactive II N/A
28/03/2025 Shandong Lukang Pharmaceutical Co., Ltd
China
SHANDONG LUKANG PHARMACEUTICAL CO LTD 25129 SPECTINOMYCIN HCL USP, NON-STERILE, BULK DRUG SUBSTANCE 2011-07-15 Active II N/A