Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062533
Company: FOUGERA PHARMS INC

Products on ANDA 062533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/1984	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
10/29/2004	SUPPL-6	Labeling		Label is not available on this site.
03/19/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/07/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/02/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/26/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062533

GENTAMICIN SULFATE

OINTMENT;TOPICAL; EQ 0.1% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	No	AT	064054	COSETTE
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	No	AT	062533	FOUGERA PHARMS INC
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	No	AT	062351	PADAGIS US
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT;TOPICAL	Prescription	No	AT	062477	TARO