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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202409
Company: AUROBINDO PHARMA LTD

Products on ANDA 202409

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 202409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2013	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
08/24/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/24/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/24/2022	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
08/24/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/24/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/24/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202409

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	207047	APPCO
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	201821	RISING

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