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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086724
Company: SUN PHARMA CANADA

Products on ANDA 086724

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086724

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/1981	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
11/02/2018	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
11/02/2018	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
09/02/2016	SUPPL-28	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/24/2006	SUPPL-20	Labeling		Label is not available on this site.
02/16/1993	SUPPL-14	Labeling		Label is not available on this site.
09/22/1989	SUPPL-13	Labeling		Label is not available on this site.
06/30/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/24/1989	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/14/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/25/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/25/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/25/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/12/1984	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/05/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/24/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086724

LIDOCAINE

OINTMENT;TOPICAL; 5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	211469	ALEMBIC
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	207810	ALKEM LABS LTD
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	206297	AMNEAL PHARMS
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	217117	AUROBINDO PHARMA LTD
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	208660	CHARTWELL RX
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	Yes	AT	080198	FOUGERA PHARMS INC
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	206498	GLENMARK PHARMS LTD
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	211697	MACLEODS PHARMS LTD
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	212695	QUAGEN
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	040911	SEPTODONT INC
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	210958	STRIDES PHARMA
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	No	AT	086724	SUN PHARMA CANADA

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