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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076453
Company: FOUGERA PHARMS

Products on ANDA 076453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076453.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/21/2004	SUPPL-5	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
07/21/2004	SUPPL-4		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
07/21/2004	SUPPL-3		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
01/21/2004	SUPPL-2		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf
06/14/2004	SUPPL-1		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076453s001s002s003s004s005.pdf

Therapeutic Equivalents for ANDA 076453

LIDOCAINE AND PRILOCAINE

CREAM;TOPICAL; 2.5%;2.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	213923	ALEMBIC
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	076320	ENCUBE
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	076453	FOUGERA PHARMS
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	212482	PADAGIS US
LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM;TOPICAL	Prescription	No	AB	219120	ZYDUS LIFESCIENCES

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