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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064030
Company: SENTISS

Products on ANDA 064030

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064030

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/1996	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
03/10/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/01/2010	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 064030

ERYTHROMYCIN

OINTMENT;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Prescription	No	AT	064067	BAUSCH AND LOMB
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Prescription	No	AT	064030	SENTISS

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