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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065442
Company: AUROBINDO PHARMA

Products on ANDA 065442

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065442

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2009	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
05/09/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/16/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/27/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/20/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065442

CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050162	PFIZER
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	065442	AUROBINDO PHARMA
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	065194	EPIC PHARMA LLC
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	216957	GLENMARK PHARMS LTD
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	065242	LANNETT
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	207402	MICRO LABS
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	065061	SUN PHARM INDS LTD
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	065217	ZYDUS PHARMS USA

CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLEOCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050162	PFIZER
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	065442	AUROBINDO PHARMA
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	065194	EPIC PHARMA LLC
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	216957	GLENMARK PHARMS LTD
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	207402	MICRO LABS
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	065061	SUN PHARM INDS LTD
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Prescription	No	AB	065217	ZYDUS PHARMS USA

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