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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062477
Company: TARO

Products on ANDA 062477

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 062477

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1983	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
07/05/1996	SUPPL-24	Labeling		Label is not available on this site.
07/05/1996	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/18/1993	SUPPL-22	Labeling		Label is not available on this site.
08/27/1992	SUPPL-21	Labeling		Label is not available on this site.
08/05/1992	SUPPL-20	Labeling		Label is not available on this site.
04/26/1991	SUPPL-19	Labeling		Label is not available on this site.
11/19/1990	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/30/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/16/1988	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062477

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

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