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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065061
Company: SUN PHARM INDS LTD

Products on ANDA 065061

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 065061

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65061ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-49	Labeling-Package Insert		Label is not available on this site.
09/12/2023	SUPPL-46	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-32	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
08/19/2019	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
12/21/2014	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
01/29/2013	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
01/29/2013	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/10/2007	SUPPL-10	Labeling		Label is not available on this site.
10/26/2005	SUPPL-6	Labeling		Label is not available on this site.
03/10/2004	SUPPL-4	Labeling		Label is not available on this site.
03/15/2002	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 065061

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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