Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040911
Company: SEPTODONT INC

Products on ANDA 040911

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 040911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2011	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-7	Labeling-Package Insert		Label is not available on this site.
11/01/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040911

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	208660	DR REDDYS
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	TARO