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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065243
Company: CHARTWELL MOLECULAR

Products on ANDA 065243

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 300MG BASE	CAPSULE;ORAL	Discontinued	None	No	No
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065243

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2005	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
08/20/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
08/20/2019	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/24/2017	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/24/2017	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/24/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/21/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/20/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/22/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/08/2007	SUPPL-4	Labeling		Label is not available on this site.
12/21/2014	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065243

CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL; EQ 75MG 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 75MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	050162	PFIZER
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	065243	CHARTWELL MOLECULAR
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	216957	GLENMARK PHARMS LTD
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	065242	LANNETT
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	207402	MICRO LABS
CLINDAMYCIN HYDROCHLORIDE	CLINDAMYCIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Prescription	No	AB	065217	ZYDUS PHARMS USA

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