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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 Apicore
India
APICORE LLC 21234 Protriptyline Hydrochloride 2008-01-15 Inactive II N/A
28/03/2025 Catalytica
India
WYCKOFF CHEMICAL CO INC 7896 PROTRIPTYLINE HYDROCHLORIDE 1989-01-28 Inactive II N/A