Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090902
Company: PADAGIS US

Products on ANDA 090902

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090902

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090902

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION;ORAL; EQ 75MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	062644	PFIZER
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	203513	AMNEAL PHARMS
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	202409	AUROBINDO PHARMA LTD
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	206958	CHARTWELL RX
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	207047	HERITAGE PHARMS INC
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	201821	LYNE
CLINDAMYCIN PALMITATE HYDROCHLORIDE	CLINDAMYCIN PALMITATE HYDROCHLORIDE	EQ 75MG BASE/5ML	FOR SOLUTION;ORAL	Prescription	No	AA	090902	PADAGIS US