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List of Drug Master Files (DMF) of Clindamycin Palmitate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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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
26/09/2024 SCI Pharmtech
Taiwan
SCI PHARMTECH INC 24917 CLINDAMYCIN PALMITATE HYDROCHLORIDE 2011-05-02 Active II Complete 2013-07-30 2013-02-19
26/09/2024 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 23436 CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) 2009-12-31 Active II Complete 2013-10-07 2013-09-26