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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062889
Company: HIKMA

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
04/25/1988 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/14/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/30/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/26/1993 SUPPL-6 Labeling

Label is not available on this site.
06/18/1991 SUPPL-5 Labeling

Label is not available on this site.
06/26/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
02/21/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
09/29/1988 SUPPL-1 Manufacturing (CMC)

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 PFIZER
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062803 PFIZER
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062800 ALMAJECT
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062943 ALMAJECT
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 062889 HIKMA
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065206 HIKMA
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
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