Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065206
Company: HIKMA

Products on ANDA 065206

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2004	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
12/20/2011	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/30/2008	SUPPL-4	Labeling		Label is not available on this site.
06/19/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065206

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	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