Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062351
Company: PADAGIS US

Products on ANDA 062351

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062351

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/1982	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
12/04/2009	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/17/2009	SUPPL-19	Labeling		Label is not available on this site.
05/21/2003	SUPPL-17	Labeling		Label is not available on this site.
11/26/2002	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/14/2002	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/21/1993	SUPPL-14	Labeling		Label is not available on this site.
07/13/1987	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062351

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 PHARMS NC
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