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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080198
Company: FOUGERA PHARMS INC

Products on ANDA 080198

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE	LIDOCAINE	5%	OINTMENT;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1972	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-30	Labeling-Package Insert		Label is not available on this site.
11/14/2000	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/07/1996	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/20/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/09/1988	SUPPL-18	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/080198Orig1s018.pdf
12/11/1987	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/09/1983	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 080198

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

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