Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062307
Company: PADAGIS US

Products on ANDA 062307

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062307

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/1981	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
12/03/2009	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
04/17/2009	SUPPL-21	Labeling		Label is not available on this site.
05/09/2003	SUPPL-18	Labeling		Label is not available on this site.
09/18/2000	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
05/21/1993	SUPPL-15	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062307

GENTAMICIN SULFATE

CREAM;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	CREAM;TOPICAL	Prescription	No	AT	064056	COSETTE
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	CREAM;TOPICAL	Prescription	No	AT	062307	PADAGIS US