Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064054
Company: COSETTE PHARMS NC

Products on ANDA 064054

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 064054

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/1994	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 064054

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