Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065347
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/09/2007 ORIG-1 Approval

Label is not available on this site.

CLINDAMYCIN PHOSPHATE

INJECTABLE;INJECTION; EQ 150MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050441 PHARMACIA AND UPJOHN
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062803 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062800 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062801 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062943 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065346 FRESENIUS KABI USA
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065347 FRESENIUS KABI USA
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204748 MYLAN LABS LTD
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204749 MYLAN LABS LTD
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090108 SAGENT PHARMS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090109 SAGENT PHARMS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062889 WEST-WARD PHARMS INT
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065206 WEST-WARD PHARMS INT

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