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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 Apotex Pharmachem
Canada
SIGNA SA DE CV 10998 RANITIDINE HCL USP 1994-08-25 Inactive II N/A
28/03/2025 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM CHEMICALS INC 11480 RANITIDINE HYDROCHLORIDE USP 1995-04-28 Inactive II N/A