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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 |
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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 |