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CLINDAMYCIN PALMITATE HYDROCHLORIDE

ANDA

CLINDAMYCIN PALMITATE HYDROCHLORIDE | A207047 | APPCO PHARMA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs3 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

PHARMACIA AND UPJOHN CO LLCCLINDAMYCIN PALMITATE HYDROCHLORIDE USP KALAMAZOO

DMF 134121998

APITORIA PHARMA PRIVATE LTDCLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 234362009

CHONGQING BIOCARE PHARMACEUTICAL LTDCLINDAMYCIN PALMITATE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG

DMF 239742010

SCI PHARMTECH INCCLINDAMYCIN PALMITATE HYDROCHLORIDE

DMF 249172011

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDCLINDAMYCIN PALMITATE HYDROCHLORIDE (PROCESS B)

DMF 272762013

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PALMITATE HYDROCHLORIDE

DMF 218962008

LUPIN LTDInactiveCLINDAMYCIN PALMITATE HYDROCHLORIDE USP

DMF 231152009

MYLAN LABORATORIES LTDInactiveCLINDAMYCIN PALMITATE HYDROCHLORIDE USP

DMF 240182010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — EQ 75MG BASE/5ML

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: May 11, 2018

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

APPCO became the applicant of record for clindamycin palmitate hydrochloride (NDA 207047) in place of Somerset Theraps LLC.

Old: SOMERSET THERAPS LLC

New: APPCO

MODIFIEDApplicant Full Name7/1/2026

APPCO Pharma LLC replaced Somerset Therapeutics LLC as the listed applicant for clindamycin palmitate hydrochloride oral solution (NDA 207047).

Old: SOMERSET THERAPEUTICS LLC

New: APPCO PHARMA LLC